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Toxicologist/Senior Toxicologist

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Position Description

The Toxicology Group provides scientific leadership and has a critical role in the drug discovery and development being conducted at Ironwood Pharmaceuticals. Ironwood is focused on three goals: transforming knowledge into medicines that make a difference for patients, creating value that will inspire the continued support of our fellow shareholders, and building a team that passionately pursues excellence.

Responsibilities:

The successful candidate is responsible for the design and implementation of nonclinical toxicology and safety pharmacology studies and interpretation of the results to support Ironwood’s drug discovery and development goals.

  • Provide leadership, functional area expertise, technical oversight, and strategic guidance for nonclinical safety studies conducted to support Ironwood discovery and development programs to ensure quality and relevance of the information to meet corporate goals;
  • Lead the design and manage nonclinical toxicology studies conducted to support multiple discovery and development programs;
  • Review, analyze, interpret and summarize toxicology data collected and manage the preparation and presentation of nonclinical safety data for project teams, regulatory agencies, management and in other internal and external arena;
  • Interact cross functionally on program teams and represent the Toxicology functional area in related scientific planning and strategic discussions;
  • Lead the selection of contract research organizations; assist in study cost negotiation and track all expenses and invoices; participate in preparing nonclinical budgets for discovery and development programs.


Requirements:

  • B.S. or M.S. with at least 5 years of experience or Ph.D. with at least 3 years of experience in preclinical toxicology and drug development in the pharmaceutical/biotechnology sector
  • Familiarity with GLP regulations and ICH/FDA guidelines for the conduct of toxicology studies to support regulatory filings
  • Experience working at or with Contract Research Organizations
  • Strong verbal, written and interpersonal communication skills

Director of Quality, GCP-GVP

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Position Description:

Reporting to the VP of Quality, the Director of Quality will be responsible for development, implementation and oversight of Good Clinical Practices (GCP) and Good Pharmacovigilance Practices (GVP) quality systems within Ironwood Pharmaceuticals. This is hands on Director level role centered on leading a risk based audit program supporting clinical and post approval development activities.

The position requires an expert knowledge of GCP and a good working knowledge of GVP. This person will act as a subject matter expert within the department and for clients group within Ironwood, as well as providing compliance oversight to external CROs. This person must be capable of formally/informally influencing, leading, and guiding both internal departments and external vendors through collaborative relationship building.

Responsibilities:

  • Ensures a robust and risk based audit program is successfully realized by leading/conducting both internal and external audits related to GCP/GVP.
  • Establish and maintain processes and tools for the preparation, conduct, reporting and follow-up of GCP/GVP audits. 
  • Collaborates with internal and external stakeholders and partners to enable and ensure appropriate implementation of the US and EU compliance requirements and associated industry guidelines as applicable to GCP/GVP. 
  • Provide senior management with in-depth analysis and risk management reports for compliance and quality related matters and recommend solutions. 
  • Ensure FDA inspection-readiness and serve as Quality Liaison for regulatory inspections and partner’s audits; provide post-inspection/audit support and follow up as required. 
  • Assist in the preparation and review of regulatory submissions for FDA and global health authorities
  • Maintain high level of awareness, expertise in international GCP/GVP regulations and provide input into the development of quality standards and procedures in related system and processes. 
  • Manage contracts and day to day activities of external contractors as needed. 
  • Develop and conduct training on current regulations and compliance issues. 
  • Represent QA at project teams and discussions for GCP/GVP related issues. 
  • Participate in team efforts to achieve departmental and company goals. 
  • Work with Program Management, Clinical Operations and Drug Safety and Pharmacovigilance to build Quality related activities into timelines.
  • Assure that the appropriate suites of Standard Operating Procedures (SOPs) are in place and optimally maintained to support the above activities.

Position Requirements:

  • BS or equivalent in a scientific discipline and 10+years of relevant experience or an advance degree and 7+ years of relevant experience within the pharmaceutical industry including a leadership role in Quality.
  • Extensive knowledge of pharmaceutical/biotech industry centered on FDA, EU, ICH, GCP/GVP. 
  • Superb organizational, interpersonal, and communication skills, both verbal and written, with the ability to facilitate meetings, conduct training and to present information in an advisory capacity.
  • Attention to detail, excellent review skills and the ability to organize and manage multiple tasks in a fast-paced environment.
  • Able to travel (some international) up to 25%. 
  • Ability to work both independently and collaboratively with project teams and cross functionally, to build productive relationships with internal and external partners, to influence decision making and to engage in conflict resolution.

Associate Scientist - Cell Based Assays

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Associate Scientist - Cell Based Assays will join a research team and be responsible for the design/execution biology experiments for the identification and validation of drug targets.

For details visit:

http://www.cwsciences.com/Current-Openings/Associate-Scientist--Cell-Based-Assays-

 

Candidates must live local and be a US Citizen or Green Card Holder

Email resume to: jobs@cwsciences.com

Commonwealth Sciences is a professional recruiting firm specializing in Science, Engineering and Green Technologies. We unite industry professionals with exciting career opportunities by leveraging our technical expertise, advanced recruiting tools and years of staffing experience. CWS works with a variety of disciplines and levels from Research Associates to Scientists, Engineers, Managers and Directors. Our clients value the basic integrity, customer service and industry expertise that defines our organization.


Commonwealth Sciences, Inc.
http://www.cwsciences.com

 

 

Research Associate

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Research Associate will be responsible for maintaining mammalian cell lines and running PCR.

 

For more information visit:

http://www.cwsciences.com/Current-Openings/Research-Associate

 

Candidates must live local and be a US Citizen or Green Card Holder

Email resume to: jobs@cwsciences.com

Commonwealth Sciences is a professional recruiting firm specializing in Science, Engineering and Green Technologies. We unite industry professionals with exciting career opportunities by leveraging our technical expertise, advanced recruiting tools and years of staffing experience. CWS works with a variety of disciplines and levels from Research Associates to Scientists, Engineers, Managers and Directors. Our clients value the basic integrity, customer service and industry expertise that defines our organization.


Commonwealth Sciences, Inc.
http://www.cwsciences.com

Senior Manager, IT Managed Production Services (600-419)

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ARIAD is a Cambridge, Massachusetts-based biotechnology company focused on cancer. We are a cohesive team of talented people from diverse backgrounds with a shared vision: We seek to transform the lives of patients with breakthrough cancer medicines. This is our purpose. This is our passion. This is our promise.

Job Summary

 

Provide a brief description of the purpose/general nature of the position; why it exists; and what the job is to accomplish.

 

Duties and Responsibilities

 

  • Maintain and develop a trusted relationship with our Managed Services Providers.
  • Responsible for the effective Management of the corporate IT infrastructure, with assistance from our MSP’s.
  • Serves as liaison for IT managed services vendors to technology planning; implementing; consulting; and supporting the infrastructure.
  • Ensure that best practices in managing a complex WAN /LAN environment. Are adhered to with assistance from MSP’s
  • Proactively monitor, scheduled software release upgrades, documentation, incident and change management, backups, disaster recovery, security, network.
  • Strengthen partnerships across IT and Business units within ARIAD Pharmaceuticals.
  • Provide consultation to business units within ARIAD Pharmaceuticals for information technology needs including advising best practices; infrastructure recommendation and implementation.
  • Develops and maintains technical and project documentation.
  • Develops and implements quality assurance test plans and quality assurance testing.
  • Coordinates project activities with appropriate departments and clients to ensure goals and requirements are met.
  • Assist in managing the Production Services support team.
  • Provide technical assistance to the Service desk where required, up to and including Incident Management.
  • Assist Management in determining, defining, and fulfilling information resources management needs; manages the design and improvement of technical processes; develops policies and procedures for the information resources management function.
  • Designs, coordinates, and evaluates training needs related to information resources management; evaluates present hardware and software and procedures in the information resources management areas and initiates or recommends changes.
  • Manage systems procurements with outside vendors.
  • Help provide direction and leadership in accordance with departmental and corporate goals.
  • Proactively seek opportunities to improve efficiencies across IT
  • Provide support for Change Management
  • Assist in budget planning, including hardware purchase/software purchase and maintenance.
  • Define and maintain IT Portfolio.
  • Ensures compliance with policies, procedures and standards, including those specifically applicable to SOX and
  • Foster a culture of exceptional customer service.

 

Qualifications

 

State the minimum qualifications required to successfully perform the job.

  • BS/BA Computer Science/Information Technology
  • Approximately 7-10 years in IT Operations/Infrastructure
  • CERTS/VM/MFST

 

The ideal candidate has:

 

  • Highly collaborative and able to manage and prioritize multiple department’s IT needs.
  • Excellent oral and written communication skills – with internal customers – and external vendors.
  • Able to handle multiple tasks in a fast-paced environment – “go extra mile” to solve customers’ problems.
  • Willingness to take initiative and follow-through - with good organizational skills, time management and attention to detail.
  • Demonstrated Team Player attitude

Submitting a resume online at a job site could cause valuable screening information to be missed.

Click here to apply:
http://ariad-openhire.silkroad.com/epostings/submit.cfm?fuseaction=app.dspjob&jobid=600&company_id=16419&jobboardid=306

ARIAD is an equal opportunity employer. The Company's policy is to afford equal employment opportunities to qualified individuals without regard to race, color, religion, national origin, ancestry, citizenship, marital status, veteran status, physical or mental disability, sex, sexual orientation or age and to comply with applicable laws and regulations. All employment decisions will be consistent with the principle of equal employment opportunity.

Procurement Systems & Data Analytical Specialist

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Req ID

5522BR

Position title

Procurement Systems & Data Analytics Specialist

Department

Purchasing

Location

US-Massachusetts

Job type

Full-time

Summary of Responsibilities

As a member of Sunovion’s Procurement team, the Procurement   Systems and Data Analytics Specialist will manage all aspects of the   procurement systems such as Oracle iProcurement, BIQ spend analytics, Ariba   eSourcing and Emptoris Contracts management and execute and deliver data driven   analysis in support department activities and initiatives. This is an   individual contributor role with direct responsibility in a procurement   business support capacity, including writing end user instructions, upgrade   testing and conducting Instructor Led Training and performing business-level   system administrator types of activities. This is a highly analytical   position requiring the ability to manipulate and derive insights from large   volumes of data.

Essential Functions

1. Drives deployment and usage of Procurement technologies and   related processes. (40%) 
  • Acts as SME and key escalation point for issues related to Procurement   business applications supported. 
  • Works with internal customers, functional areas and suppliers to optimize   procurement systems performance; troubleshoots and resolves issues. 
  • Works with business units to understand business processes and how   Procurement applications can support business requirements. 
  • Applies knowledge to effectively solve problems. Develops and maintains   Procurement systems-related training materials and programs 
  2. Responsible for managing maintenance, support and enhancements of   Procurement tools in alignment with associated processes (20%) 
  3. Defines and maintains data management standards to ensure the delivery of   consistent, accurate business analysis and metrics for key department   activities, including: (40%) 
  • Spend categorization 
  • Spend assessments 
  • Cost savings/avoidance analysis 
  • Activity based reporting for cost savings and avoidance, strategic sourcing   and contract management 
  • Procurement cycle times 
  • Compliance reporting

Minimum education requirements

Bachelors

Experience required

3 - 5 Years

Knowledge & skills (general and technical)

Education level and/or relevant experience(s): 
  • Bachelor’s degree in Supply Chain, Business, Finance, Technology Management   or related/equivalent work experience required 
  • Minimum 3-5 years progressive responsibility with procurement systems   management experience 
  • Demonstrated expertise in manipulating large datasets and with Microsoft   Office Suite applications: Excel, Access, PowerPoint and Word 
  • Detail oriented with excellent organizational, problem solving,   communication, and professional interpersonal skills 
  • Critical thinking, possess initiative and ability to work independently and   in a team environment towards assigned goals. 
  • Exceptional track record of data driven analysis 
  • Experience analyzing data to support projects and initiatives with   fact-based conclusions. 
  • Excellent verbal and written communication skills. 
  • Experience working with all levels of internal customers and external   service providers to fulfill organizational needs. 
  • Must be resourceful, proactive and responsive 
  • Must be self-motivated and have the ability to effectively manage multiple   & competing projects & tasks

Other requirements (licenses, certifications, specialized   training, physical or mental abilities required)

• Knowledge of, or ability to learn, Procurement systems is   required – tools for Spend Analytics and eSourcing, Contracts, Requisitions,   Purchase Orders 
  • Experience with Oracle iProcurement/ Purchasing/ Accounts Payable is   preferred 
  • Experience with Contract Management Systems is desired 
  • Experience with leading people within a training program and collaborating   with colleagues for systems implementations is required 
  • Pharmaceutical/Biotech industry experience is desirable 
  • SDLC and PMBOK skills desirable 
  • All information (written, verbal, electronic, etc.) that an employee   encounters while working at Sunovion is considered confidential

Confidential Data

All information (written, verbal, electronic, etc.) that an   employee encounters is considered confidential.

Compliance

Achieve and maintain Compliance with all applicable regulatory,   legal and operational rules and procedures, by ensuring that all plans and   activities for and on behalf of Sunovion are carried out with the   "best" industry practices and the highest ethical standards.

Mental/Physical Requirements

Fast paced environment handling multiple demands. Must be able   to exercise appropriate judgment as necessary. Requires a high level of   initiative and independence. Excellent written and oral communication skills   required. Requires ability to use a personal computer for extended periods of   time.

 

Procurement Systems & Data Analytics Specialist

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Req ID

5522BR

Position title

Procurement Systems & Data Analytics Specialist

Department

Purchasing

Location

US-Massachusetts

Job type

Full-time

Summary of Responsibilities

As a member of Sunovion’s Procurement team, the Procurement   Systems and Data Analytics Specialist will manage all aspects of the   procurement systems such as Oracle iProcurement, BIQ spend analytics, Ariba   eSourcing and Emptoris Contracts management and execute and deliver data driven   analysis in support department activities and initiatives. This is an   individual contributor role with direct responsibility in a procurement   business support capacity, including writing end user instructions, upgrade   testing and conducting Instructor Led Training and performing business-level   system administrator types of activities. This is a highly analytical   position requiring the ability to manipulate and derive insights from large   volumes of data.

Essential Functions

1. Drives deployment and usage of Procurement technologies and   related processes. (40%) 
  • Acts as SME and key escalation point for issues related to Procurement   business applications supported. 
  • Works with internal customers, functional areas and suppliers to optimize   procurement systems performance; troubleshoots and resolves issues. 
  • Works with business units to understand business processes and how   Procurement applications can support business requirements. 
  • Applies knowledge to effectively solve problems. Develops and maintains   Procurement systems-related training materials and programs 
  2. Responsible for managing maintenance, support and enhancements of   Procurement tools in alignment with associated processes (20%) 
  3. Defines and maintains data management standards to ensure the delivery of   consistent, accurate business analysis and metrics for key department   activities, including: (40%) 
  • Spend categorization 
  • Spend assessments 
  • Cost savings/avoidance analysis 
  • Activity based reporting for cost savings and avoidance, strategic sourcing   and contract management 
  • Procurement cycle times 
  • Compliance reporting

Minimum education requirements

Bachelors

Experience required

3 - 5 Years

Knowledge & skills (general and technical)

Education level and/or relevant experience(s): 
  • Bachelor’s degree in Supply Chain, Business, Finance, Technology Management   or related/equivalent work experience required 
  • Minimum 3-5 years progressive responsibility with procurement systems   management experience 
  • Demonstrated expertise in manipulating large datasets and with Microsoft   Office Suite applications: Excel, Access, PowerPoint and Word 
  • Detail oriented with excellent organizational, problem solving,   communication, and professional interpersonal skills 
  • Critical thinking, possess initiative and ability to work independently and   in a team environment towards assigned goals. 
  • Exceptional track record of data driven analysis 
  • Experience analyzing data to support projects and initiatives with   fact-based conclusions. 
  • Excellent verbal and written communication skills. 
  • Experience working with all levels of internal customers and external   service providers to fulfill organizational needs. 
  • Must be resourceful, proactive and responsive 
  • Must be self-motivated and have the ability to effectively manage multiple   & competing projects & tasks

Other requirements (licenses, certifications, specialized   training, physical or mental abilities required)

• Knowledge of, or ability to learn, Procurement systems is   required – tools for Spend Analytics and eSourcing, Contracts, Requisitions,   Purchase Orders 
  • Experience with Oracle iProcurement/ Purchasing/ Accounts Payable is   preferred 
  • Experience with Contract Management Systems is desired 
  • Experience with leading people within a training program and collaborating   with colleagues for systems implementations is required 
  • Pharmaceutical/Biotech industry experience is desirable 
  • SDLC and PMBOK skills desirable 
  • All information (written, verbal, electronic, etc.) that an employee   encounters while working at Sunovion is considered confidential

Confidential Data

All information (written, verbal, electronic, etc.) that an   employee encounters is considered confidential.

Compliance

Achieve and maintain Compliance with all applicable regulatory,   legal and operational rules and procedures, by ensuring that all plans and   activities for and on behalf of Sunovion are carried out with the   "best" industry practices and the highest ethical standards.

Mental/Physical Requirements

Fast paced environment handling multiple demands. Must be able   to exercise appropriate judgment as necessary. Requires a high level of   initiative and independence. Excellent written and oral communication skills   required. Requires ability to use a personal computer for extended periods of   time.

 

Reaction Engineer

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About CONTINUUS Pharmaceuticals

CONTINUUS Pharmaceuticals is a spin-out company of a $65 million collaboration between MIT and Novartis on continuous manufacturing. CONTINUUS designs and develops innovative continuous manufacturing processes for pharmaceutical clients, providing them with an exceptional “one-shop solution” for the entire drug development and manufacturing cycle.

Rather than producing medicines through batch-wise, step-by-step processes, CONTINUUS Pharmaceuticals offers a breakthrough Integrated Continuous Manufacturing (ICM) technology for small molecule pharmaceuticals. The synthesis of the active ingredient and the final dosage form are integrated into a seamless and completely automated process. This novel method will allow “on-demand” manufacturing of pharmaceuticals with significant advantages in production lead time, quality, and cost.

CONTINUUS is working with several major pharmaceutical and generic companies on the implementation of ICM for both novel and already-marketed drugs. New hires will work directly on these projects.

Learn more at: http://continuuspharma.com

Job Posting

CONTINUUS is looking to hire a full-time reaction engineer to work on the development of continuous manufacturing processes for pharmaceuticals. This represents a unique opportunity to be involved in the development of next generation drug manufacturing technologies as a key member of a fast-growing MIT start-up company. The candidate is expected to lead the reaction engineering efforts at CONTINUUS, as well as to perform the necessary experimental work to ensure process performance goals are met.

We seek candidates with a PhD in chemical engineering, and expertise in chemical reaction engineering. 1-3 years of industrial experience is preferred, but not necessary. Candidates will be working at our facility in Woburn (25-R Olympia Avenue, Woburn, MA 01801).


Research Associate/Sr. Research Associate, Protein Purification and Characterization

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Research Associate / Sr. Research Associate, Protein Purification and Characterization

                                                              

 

Summary of Position:

Scholar Rock is seeking an outstanding individual with protein purification and characterization experience to join our research team in discovering and developing novel biologic therapies, called “niche modulators” that target protein growth factors in the disease microenvironment. The successful candidate will be involved in the purification and characterization of novel and diverse set of protein biologics and antibodies that specifically modulate the function of disease-causing growth factors in such therapeutic areas as fibrosis, musculoskeletal diseases, and autoimmunity.

 

Position Responsibilities:

As a member of our Protein Science team, the candidate will be responsible for: 

  • Purification  and characterization of antigens and antibodies to support the Discovery  Research team at both small and large scale amounts
  • Perform stability and pre-formulation studies on antibody candidates
  • Generate and provide protein reagents in a timely manner to colleagues to support Discovery Research
  • This position will provide the opportunity to make visible contributions to a variety of projects while interacting with a knowledgeable and dedicated multidisciplinary team.

 

Candidate Requirements:

  •  BS or MS in molecular biology, biochemistry, biophysics or related field with 5+ years of industry experience.
  • Experience with various protein purification techniques including affinity, IEX, SEC, HIC, and reverse phase chromatography
  • Experience with protein characterization techniques including SDS-PAGE, DSC/DSF, SEC-MALS, DLS is also required
  • Experience with kinetic and thermodynamics measurements is a plus
  • Skilled in standard molecular biology techniques
  • Strong written and verbal communication skills.
  • The individual should be able to function in a timeline-driven, dynamic environment, and be able to rapidly adapt to new techniques and protocols. A strong work ethic and high-level motivation are required.
  • The successful candidate should have the ability to work both independently and as part of a team to meet deadlines and contribute to the strategic goals of the company.

 

Crystallization Engineer

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About CONTINUUS Pharmaceuticals

CONTINUUS Pharmaceuticals is a spin-out company of a $65 million collaboration between MIT and Novartis on continuous manufacturing. CONTINUUS designs and develops innovative continuous manufacturing processes for pharmaceutical clients, providing them with an exceptional “one-shop solution” for the entire drug development and manufacturing cycle.

Rather than producing medicines through batch-wise, step-by-step processes, CONTINUUS Pharmaceuticals offers a breakthrough Integrated Continuous Manufacturing (ICM) technology for small molecule pharmaceuticals. The synthesis of the active ingredient and the final dosage form are integrated into a seamless and completely automated process. This novel method will allow “on-demand” manufacturing of pharmaceuticals with significant advantages in production lead time, quality, and costs.

CONTINUUS is working with several major pharmaceutical and generic companies on the implementation of ICM for both novel and already-marketed drugs. New hires will work directly on these projects.

Learn more at: http://continuuspharma.com

Job Posting

CONTINUUS is looking to hire a full-time crystallization engineer to work on the development of continuous manufacturing processes for pharmaceuticals. This represents a unique opportunity to be involved in the development of next generation drug manufacturing technologies as a key member of a fast-growing MIT start-up company. The candidate is expected to lead the crystallization engineering efforts at CONTINUUS, as well as to perform the necessary experimental work to ensure process performance goals are met.

We seek candidates with PhD in chemical engineering, and expertise in separations, purification/crystallization, and solid-liquid filtration. 1-3 years of industrial experience is preferred, but not necessary. Candidates will be working at our facility in Woburn (25-R Olympia Avenue, Woburn, MA 01801).

Senior Billing Specialist

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Senior Billing Specialist that will be primarily responsible for generation of project invoice transactions and ensuring the integrity and accuracy of accounts receivable; which includes timely billings and collections and Contract Management. This position interacts closely with the company’s Contracts and Project Management departments.

Specific Responsibilities include:

  • Effectively communicate with Project Managers (PM), Business Development (BD) and Contracts, regarding contract documents, change orders and other contract modifications, approvals, and any additional services-related to billing.
  • Prepare and issue monthly invoices for all billable projects, hourly, unit and pass-through.
  • Ensure the timely and accurate processing and tracking of customer contracts and change orders and service invoices.
  • Research, review, obtain approval and process credit memo requests.
  • Meet departmental billing deadlines.
  • Assist PM with customer billing inquiries.
  • Research unpaid or disputed amounts and work with Contracts, Project Management and Finance departments to resolve customer issues and correct billing errors.
  • Monthly prepare various client financial summaries and estimates.
  • Assess and pursue opportunities for maximization of client billing; communicate with the Controller as to your observations and actions taken.
  • Research any unbilled issues to optimize the billing possibilities for the billing period.
  • Provide the accounts payables team member with advice on client billing, relative to consultant invoicing and reimbursable expenses.
  • It is expected that the Billing Specialist maintain a continuous line of communication to clear any open issues.
  • Work with the cash receipts team member to reconcile variances that occur in the application of cash.
  • Generate and distribute monthly receivables reports and monthly profitability reports.
  • Maintain deferred revenue balance, keep current on a monthly basis and reconcile to general ledger.
  • Review weekly time sheets, along with the PM group.
  • Recommend and implement agreed process improvements to the billing cycle.
  • Prepare special project analyses for the PMs and others.
  • Provide year-end support of auditor requirements, which may include research and reconcilement.
  • Perform additional assignments, as directed by the Controller.

Minimum Requirements:

  • Bachelor’s Degree in accounting or business preferred.
  • Intermediate to advanced computer literacy, including experience in word processing, spreadsheets and accounting software.
  • 3 years of billing experience.
  • Knowledge of project management software, a plus.
  • A thorough knowledge of standard contract terms, including hourly,      milestone, not-to-exceed and how they are applied in the billing process.
  • Ability to work well with others under deadline situations and respond to changes in priorities.
  • Good written and verbal communication skills and strong organizational skills and a strong attention to detail.
  • Ability to work independently, take initiative, set priorities and see projects through to completion.
  • Employ problem-solving skills and analysis, and report problems to the Controller, as necessary.
  • Strong service orientation.
  • Strong accounting foundation required. Revenue recognition experience is a plus.
  • Strong understanding of contract billing.
  • Self-motivated professional with a strong work ethic and the ability to establish relationships and interact with executives, co-workers, and customers with ease. This individual must be highly ethical, dependable and diligent, and enjoy working in fast paced, always changing environment.
  • Ability to navigate internal and external organizational obstacles and work with all employee levels to solve problems.
  • Ability to organize, meet strict deadlines and work both independently and as part of a team.
  • Knowledge of the project structure in a client/consultant business environment.

Principal Research Associate, Non-Clinical Sciences (375-979)

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Position Summary
The Non-clinical Sciences team at Moderna is looking for an agile, high-performing, and broadly-skilled individual to contribute to successful execution in both discovery and development programs. The majority of this work will be done in collaboration with internal partners and executed at external contract research organizations (CROs). The successful candidate will be able to manage and prioritize multiple concurrent work streams with a positive and collaborative mentality and with the ability to manage workload to meet project timelines.

Responsibilities
* Collaboration with program scientists to execute and manage outsourced studies
* Collaboration with internal partners from different functional groups at Moderna (e.g. New Venture Labs, Chemistry, Formulations, Cell Biology, Drug Product Development, Therapeutic Area Ventures, Finance)
* Manage relationships with contract research organizations
* Protocol and report review management, including execution of protocol review meetings
* Management of documentation related to managed studies (e.g. quotes, POs, protocols, data, reports)
* Non-clinical toxicology, pathology, and DMPK data and report review/QC
* Management of financial aspects of upcoming studies, including forecasting and quote/PO coordination

Minimum Qualifications
* Life sciences bachelor's degree with at least 5 years of pharmaceutical non-clinical study management experience, including both GLP and nonGLP
* Very high proficiency with Windows-based applications (e.g. Excel, Word, Outlook, Powerpoint).

Preferred Qualifications
* CRO Experience (e.g. study coordinator, study director)
* Pharma/biotech Experience (e.g. study monitoring, scientific project management, non-clinical in vivo management

Competencies:
* Proactive
* Collaborative
* Eager to learn
* High attention to detail
* Positive mental attitude
* Flexible/Adaptable to change
* Effective written and oral communication
Why Join Moderna

Moderna is pioneering messenger RNA Therapeutics™, an entirely new in vivo drug modality that produces human proteins or antibodies inside patient cells, which are in turn secreted or active intracellularly. This breakthrough platform addresses currently undruggable targets and offers a superior alternative to existing drug modalities for a wide range of disease conditions. Moderna has developed a broad intellectual property estate, including more than 250 patent applications covering novel nucleotide chemistries and drug compositions. The company plans to develop and commercialize its innovative mRNA drugs through a combination of strategic relationships as well as newly formed ventures.

Founded in late 2010 by Flagship VentureLabs, Cambridge-based Moderna is privately held and currently has strategic agreements with AstraZeneca and Alexion Pharmaceuticals.

Moderna recently signed a collaboration agreement with Astra Zeneca that provided a $240MM upfront payment (plus milestone payments).

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Please apply at: Application URL:http://www.aplitrak.com/?adid=YWxsaXNvbi5tYXllci4xODgwNS4zMTY3QG1vZGVybmF0aGVyYXBldXRpY3NpbmMuYXBsaXRyYWsuY29t

Global Development Team Lead, VP (Complement Biology)

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Primary Role:
The VP-Global Development Team Leader (GDTL) will be responsible for the leadership and matrix management of all aspects of multiple Development programs, from the end of preclinical development stage through post commercialization. Will coordinate and manage team activities tailored to address the specific needs of individual programs, and identify innovative approaches to both increase the speed with which therapies can get to market and enhance the value of programs as assessed by alignment with Target Product Profiles (TPPs) and stakeholders in the "Circle of Value". Will work with Therapeutic Area Head to define and implement best practices and balance resources across the Development portfolio.

Key accountabilities:
* Lead the multidisciplinary Global Development Team(s) and, if applicable, closely collaborate with the Product Strategy Team (PST and the Product Strategy Team Lead (PSTL) to provide and execute strategic development plans to rapidly address key unmet medical needs and meet the strategic imperatives of the appropriate business unit (BU)
* Matrix management of GDT members
* Ensure all clinical documents have proper accuracy content: CSRs, Regulatory documents, as the individual is ultimately responsible for overall strategy, tactics and deliverables for the program
* Lead complex development programs such as ones with multiple indications and/or multiple geographic regions and broadly contribute to strategic thinking at the Therapeutic Area Level
* Engagement and communication across business units and functional lines
* Partnership with Program management (PM) representative on the GDT to ensure consistent high quality input from the team, and engagement with PM with regard to exploring opportunities to enhance speed and/or project value
* Overall development Strategy and Plan and resource and budget planning
* Assessment of BD opportunities which could impact on Development programs, monitoring external scientific information and competitor activity related to Development programs and modifying program strategy as appropriate.
* Tracking progress against project goals and composing monthly reports for senior management and Shire Leadership teams outlining key strategic events for projects. These documents contain program milestones, strategic imperatives, and financial information regarding projects.
* Responsibilities may include post-marketing commitments and life cycle management initiatives
* An as experienced Clinical Development professional, take a hands-on role in establishing a detailed clinical development plan, possibly working with a less experienced Clinical representative on the team(s)
* Be a lead clinical representative at key external meetings (e.g. with regulatory authorities) and may present at regulatory advisory meetings
* Line management and/or mentorship of global clinical development leads (GCDLs) and/or less experienced GDTLs
* Be key point of contact for external key opinion leaders, and potentially media

Education & Experience Requirements:
* MD with deep experience managing Clinical Development projects in pharmaceutical or biotech company. Experience in small and large pharma and in different business models preferred
* Experience in development in Immunology and/or Transplant required
* Strong knowledge and understanding of regulatory requirements for product approval and compliance in US and Europe, experience in global drug development
* Extensive experience of team leadership in a matrix management environment
* Aware of changing trends in pharmaceutical drug development, and experience in applying new approaches
* Experience with drugs at all stages of development and presenting data to regulatory agencies/Advisory committees. Experience in taking drugs to market preferred
* Solid experience with external Scientific Advisory Boards and publication record preferred

Other Job Requirements:
* Domestic and international travel as required for face to face meetings with key stakeholders and attendance at external scientific and business meetings. Must be prepared to present at small and large external meetings on behalf of Shire

Shire's Brave culture offers employees with diverse backgrounds the opportunity to enable those with life altering conditions to lead better lives. Shire is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by applicable law. US Applicants who require accommodation in the job application process may contact 484-595-8400.

Application URL:http://www.aplitrak.com/?adid=YXN0YW5pdHMuNzcyOTcuMzE2N0BzaGlyZS5hcGxpdHJhay5jb20

Director, Pharmaceutical Development Knowledge Management

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Primary Role
* The Knowledge Management (KM) Lead is responsible for developing and overseeing the Pharmaceutical Development (PD) Department CMC Knowledge Management strategy and execution to facilitate knowledge capture (data and documents), sharing and archiving.
Develop and oversee a comprehensive integrated KM strategy for pharmaceutical product knowledge which facilitates data capture, document management, knowledge sharing and collaborations across the pharmaceutical development spectrum. Align with Corporate, Legal, Regulatory and Operational mandates for data/document retention.
* This will include standard and novel approaches to capture data from multiple internal and external sources. Identify and seek out opportunities to better leverage captured knowledge across the product life-cycle to enable information and knowledge to grow, flow and create value. Develop a culture of integrated KM that engages people, platforms and business processes that facilitates effortless information flow.
Ensure visibility and alignment with Technical Operations, Quality, Regulatory, Commercial Manufacturing, IT, Records and Information Management (RIM) and other potential cross functional stakeholders.
* Following asset acquisitions, mergers, divestments and site transitions announcements work to ensure the integrity of the pharmaceutical product data and documents (structured, unstructured, system/application and physical records) is safeguarded and full pharmaceutical product knowledge transfer occurs in a timely fashion.
Additionally, when required, the Director supervises and coaches junior staff and supports the department with continuous improvement activities

Responsibilities
35% Knowledge Management Strategy
* Creation and oversight of a strategy, principles and roadmap for pharmaceutical product knowledge management. Identify and understand user's needs and priorities, evaluate existing resources, systems, external vendors and potential partners.
* In collaboration with cross functional stakeholders ensure existing enterprise-wide technology is thoroughly investigated and fully deployed to support functional groups by integration of information systems, exploring expanded tool optimization through in house expertise or external partnerships, leverage of systems situated across departments to increase flow of knowledge, maximize data mining services to allow analysis of results, data visualization, and trend analysis where appropriate.
* Where new or innovative tools are identified to increase productivity or value work with business owners to lead business case creation and approval and secure necessary resources to support strategic vision.
* Collaborate with IT to explore and implement technology and information tools and platforms to provide KM services where necessary.
* In relation to KM compliance; acts as the SME for pharmaceutical development in data integrity, CSV, GAMP, GxP assessment as it relates to information management systems used by the department

35% Knowledge Management Execution
* Actively manages the delivery of established knowledge management systems and processes to service the department. Understand the advantages and constraints of existing technologies and systems
* Actively manages the development, delivery, training and implementation of any future selected systems and strategies for the department
* Develop business capabilities and support model for sustaining the flow of knowledge, establishing, maintaining and demonstrating the connection to improved business outcomes
* Seek regular customer feedback for evaluation and enhancement of the KM lifecycle

20% Integration Lead
* Following asset acquisition provides oversight and management of pharmaceutical product knowledge transfer.
* Works closely with pharmaceutical development teams to identify information need and ensure deliverables are met in line with products goals. Actively prioritizes KM activities.
* Works actively with IT business leads to identify and deploy automated and GxP compliant knowledge transfer where feasible.
* Quickly and proactively develops relationships and acts as the conduit from transferee to receiver functions at Shire.
* Ensures essential transferee data /document storage locations are identified and safeguarded to assure business continuity (includes structured, unstructured, system/application, electronic and paper locations)
* Leads, participates and actively contributes to functional knowledge integration discussions.
* Provides project management capabilities for more complex integrations
* Uses experience, feedback and evaluations to develop and maintain sustainable business model for future integrations
* Provide regular and comprehensive updates to senior management, identifying opportunities, constraints and needs.

10% General
* Mentors and coaches junior staff within the department.
* Assists in the development and implementation of departmental processes, procedures and policies.
* Maintains a high level of professional expertise through familiarity with regulations, scientific literature and participation in training courses.
* Attends relevant internal training courses and is responsible for implementation of systems within the department.

Education & Experience Requirements
* Bachelor's degree (or higher)
* Minimum 15 years' experience in the Pharmaceutical Industry or related IT, Quality, Compliance or Regulatory field. Familiarity with the objectives and processes across multi-disciplinary functions involved in drug development, registration and quality (GxPs) is essential
* Proven working knowledge of global GMP and ICH guidelines and regulatory requirements. Specifically Internation¬al Conference on Harmonization (ICH) guidelines which establish the paradigm for Quality by Design and develop¬ment and manufacture of drug substances, specifically ICH Q8 (R2) Pharmaceutical Development, ICH Q9 Quality Risk Management, ICH Q10 Pharmaceutical Quality Sys¬tem, and ICH Q11 Development and Manufacture of Drug Substances is essential
* Proven experience in leading successful change management projects is essential
* Experience of small molecule and biologic manufacture through outsourcing and insourcing models is essential.
* Strong knowledge and hands on experience with multiple IT solutions commonly used in the industry for data capture and utilization is required
* Strong working knowledge of GxP, GAMP, CSV and data integrity principles is required
* Knowledge and/or application of pharmaceutical development, technology/product transfer, commercial manufacturing is desirable
* Operational Excellence knowledge is desirable
* Strong knowledge of Quality Systems; CAPA, Change Control and Deviation principles is desirable
* Proven experience in an information management role providing data analytics capability and system suitability assessments is desired

Shire's Brave culture offers employees with diverse backgrounds the opportunity to enable those with life altering conditions to lead better lives. Shire is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by applicable law. US Applicants who require accommodation in the job application proces

Application URL:http://www.aplitrak.com/?adid=amVucy43NzI1NS4zMTY3QHNoaXJlLmFwbGl0cmFrLmNvbQ

Statistician - Biotherapeutics Pharmaceutical Research and

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Org Marketing Statement
A career at Pfizer offers opportunity, ownership and impact.

All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere.Our colleagues have the opportunity to grow and develop a career that offers both individual and company success;be part of an ownership culture that values diversity and where all colleagues are energized and engaged;and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the biopharmaceutical industry,is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.

Role Description
The Pharmaceutical Science and Manufacturing Statistics group supports a wide variety of activities in drug development and manufacturing spanning both new chemical and biological entities. This position is located at the Andover, MA facility.

Responsibilities
The successful candidate will:
* Provide primary statistics support to the science and technology lines within Biotherapeutics Pharmaceutical Sciences: spanning drug substance, drug product, and analytical method development, as well as regulatory activities.
* Collaborate with scientists to plan meaningful studies/experiments, statistically analyze, and communicate / document the results.
* Demonstrate leadership in influencing and improving workflows by identifying, developing, and applying new quantitative methods as needed to solve problems in pharmaceutical research.
* Participate in the group's education initiative by teaching courses such as experimental design, measurement systems analysis, and linear/non-linear regression.
* Pursue business-related research interests and represent Pfizer externally.

Qualifications
Requirements:
* MS in Statistics, with two or more year's statistical consulting experience, preferably in a laboratory science environment or a PhD in Statistics with at least one year of statistical consulting experience.
* Statistical knowledge through coursework and/or demonstrated statistical application in general linear models, mixed models, non-linear models, experimental design, variance components, and quality control.
* Familiar with basic chemistry, biology, and / or engineering.
* Sound computational skills: SAS, S+ / R, or equivalent, and knowledge of a variety of commercial packages.
* Exceptional oral and written communication skills in explaining complex statistics in the context of experimental objectives to those with little or no statistical background.

Desired:
* Prior experience working in pharmaceutical research and development, specifically with protein-based therapies.
* Proven track record of integrating statistical techniques and solutions into pharmaceutical / engineering applications to achieve business results.
* Statistical experience in a regulated scientific environment and knowledge of ICH guidance and pharmacopoeia monographs
* The flexibility to balance many projects and customers simultaneously.
* The ability to be independent and learn new skills quickly.
* The aptitude to identify and understand relevant scientific literature and apply knowledge gained from these sources.
* Familiar with the drug development and manufacturing process
* Basic knowledge of Quality by Design or Design for Six-Sigma

EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

Application URL:http://www.aplitrak.com/?adid=amVmZnJleXN0b25lLjkyMTc1LjMxNjdAcGZpemVyLmFwbGl0cmFrLmNvbQ


Scientist, Cell Line Development

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Org Marketing Statement
A career at Pfizer offers opportunity, ownership and impact.

All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere.Our colleagues have the opportunity to grow and develop a career that offers both individual and company success;be part of an ownership culture that values diversity and where all colleagues are energized and engaged;and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the biopharmaceutical industry,is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.

Role Description
A technical, lab-based position is available within Pfizer's Cell Line Development organization. The position will primarily be responsible for the development of cell lines with particular responsibility for following Cell Line Development platform/ work practices to develop and characterize mammalian cell lines. Working as part of a team this role will involve all aspects of cell line development from vector construction, cell culture maintenance and clone screening to cell line characterization. The successful candidate will possess excellent aseptic technique and have experience with mammalian cell culture. Must be familiar with DNA sequencing technologies and analysis of DNA sequencing data - multiple sequence alignments, identification of mutant sequences, in silico protein translation, etc. Experience with molecular cloning techniques such as plasmid construction, preparation and analysis, RNA, cDNA and genomic DNA preparation, DNA electrophoresis, and Northern and Southern analyses is highly desired.

Familiarity with automation technologies would be a definite plus. This position will also contribute to CLD novel technology development and work process optimization activities as appropriate.

Responsibilities
* Be a key member of the Cell Line Development team that will support the execution of cell line development projects, including maintenance of host cells, clone selection and cell line characterization.
* Perform basic cloning and DNA prep. Set up and perform PCR reactions.
* Perform electrophoresis, Southern and Northern Blot analyses.
* Support laboratory activities by monitoring lab equipment and maintaining a clean and safe working environment.
* Demonstrate excellent communication and presentation skills, a documented ability to troubleshoot technical issues, an ability to plan and carry out experiments independently, and to work with complex instrumentation and software.
* Effectively document all lab activities in notebooks/ elsewhere as required and appropriate, in a timely fashion; authors technical reports as needed and contributes to internal/ external posters/ publications as appropriate.
* Evaluate data and provide clear reports that can be shared and transferred to and from cross-functional teams; responsible for clear communication in both written and oral forms.
* Pay attention to detail, strictly adhere to safety protocols, and use knowledge of basic laboratory procedures to advance projects under rapidly shifting priorities and timelines.
* The successful applicant will work with, and contribute to associated Regulatory filing activities.

Qualifications
Requires BS or MS in cellular/molecular biology or related field and at least three years of laboratory experience. Must be familiar with DNA sequencing technologies and analysis of DNA sequencing data - multiple sequence alignments, identification of mutant sequences, in silico protein translation, etc. Experience with molecular cloning techniques such as plasmid construction, preparation and analysis, RNA, cDNA and genomic DNA preparation, DNA electrophoresis, and Northern and Southern analyses is highly desired.

EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

Application URL:http://www.aplitrak.com/?adid=amlsbC5jdXR0aW5nLjk1NzYzLjMxNjdAcGZpemVyLmFwbGl0cmFrLmNvbQ

Associate Scientist, Molecular and Cellular Biology at Unum Therapeutics

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Associate Scientist, Molecular and Cellular Biology at Unum Therapeutics

Who are we?

Recent advances in T-cell engineering and antibody therapeutics have led to phenomenal results in treating cancer patients, opening the possibility for combining these powerful therapeutic modalities. Unum Therapeutics aims to transform cancer treatment through the discovery, development, and commercialization of novel cellular immunotherapies. We’re moving forward fast, are you? Visit www.unumrx.com for our latest news!

What are we offering to you?

This is an outstanding opportunity to be a founding member and scientific leader of an early-stage, well funded, start-up company. You will be a vital part of helping to achieve the Unum vision: to transform cancer treatment and deliver patient cures.  Unum is a place where your input matters -- you will have a direct impact on our science and will help to build our capability as a team. You will also shape the Unum culture and be a part of a passionate, transparent, and collaborative work environment. 

We are seeking a high-energy, flexible molecular and cellular biologist to be a key contributor to the in vitro biology efforts at Unum.

What will you be doing?

  • Generating and characterizing modified cell lines and primary cells through transient and stable transfection, mRNA, viral transduction, and gene editing technologies.
  • Developing cell-based assays using primary cells and cell lines with a variety of analysis methodologies, including flow cytometry, ELISA, and luminescence.
  • Contributing to drug discovery and technology development projects through collaboration across scientific groups at Unum.
  • Contributing to other initiatives as they arise in our fast paced start-up environment.

Who are we seeking?

  • BS with at least 3 years or MS with at least 1 year of relevant experience in an industry (preferred) or academic setting.
  • Experience with cell line generation and/or gene editing technologies.
  • Experience developing cell-based assays with different analysis strategies (e.g. flow cytometry, ELISA, luminescence).
  • Experience with primary cell lines, immunology, and/or cancer biology is a plus.
  • Outstanding written and oral communication skills, and ability to work in a collaborative setting.

 Where are we?

Unum is located in a new facility located within walking distance of the Alewife T station in Cambridge, MA. Our space includes an open office layout designed for collaboration and state-of-the-art laboratories. Free access is provided for both on-site parking and gym facilities in the building.  We are in close proximity to leading academic institutions like MIT and Harvard and to potential pharmaceutical and biotech partners.  This unique location allows for a high level of energy and intellectual exchange within and among fast growing early stage companies.

What benefits does Unum offer?

To attract the very best talent, we offer a generous benefits package that includes competitive pay, performance-based bonus, stock options, insurance coverage (health, dental, life, and disability), trust-based time-off, a 401(k) plan,and commuter/parking benefits.

How to Apply?

Please send cover letter and resume to: careers@unumrx.com

Unum is an equal opportunity employer.

We are only accepting applications from candidates with authorization to work in the United States at this time.

Note to agencies – we are not accepting unsolicited resumes from agencies and will not be responsible for fees associated with any such submittals.

 

 

Associate Scientist, In Vitro Cancer Biology at Unum Therapeutics

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Associate Scientist, In Vitro Cancer Biology at Unum Therapeutics

Who are we?

Recent advances in T-cell engineering and antibody therapeutics have led to phenomenal results in treating cancer patients, opening the possibility for combining these powerful therapeutic modalities. Unum Therapeutics aims to transform cancer treatment through the discovery, development, and commercialization of novel cellular immunotherapies.We’re moving forward fast, are you? Visit www.unumrx.com for our latest news!

What are we offering to you?

This is an outstanding opportunity to be a founding member and scientific leader of an early-stage, well funded, start-up company. You will be a vital part of helping to achieve the Unum vision: to transform cancer treatment and deliver patient cures.  Unum is a place where your input matters -- you will have a direct impact on our science and will help to build our capability as a team. You will also shape the Unum culture and be a part of a passionate, transparent, and collaborative work environment.

We are seeking a high-energy, flexible in vitro cancer biologist to be a key contributor to the in vitro biology efforts at Unum.

What will you be doing?

  • Contributing to the characterization of oncology targets through the development of cell-based assays using primary cells and cell lines.
  • Contributing to the validation of oncology targets by characterizing primary cells and cell lines using a variety of assays (e.g. expression, signaling, proliferation) and analysis methodologies (e.g. qPCR, western blot, flow cytometry, ELISA).
  • Contributing to drug discovery and technology development projects through collaboration across scientific groups at Unum.
  • Contributing to other initiatives as they arise in our fast paced start-up environment.

Who are we seeking?

  • BS with at least 3 years or MS with at least 1 year of relevant experience in an industry (preferred) or academic setting.
  • Experience working on cancer biology projects, ideally in a therapeutic setting.
  • Experience developing cell-based assays and characterizing mammalian cells with different analysis strategies (e.g. flow cytometry, ELISA, PCR, western blot).
  • Experience validating tumor antigens for biotherapeutics is a plus.
  • Outstanding written and oral communication skills, and ability to work in a collaborative setting.

Where are we?

Unum is located in a new facility located within walking distance of the Alewife T station in Cambridge, MA. Our space includes an open office layout designed for collaboration and state-of-the-art laboratories. Free access is provided for both on-site parking and gym facilities in the building.  We are in close proximity to leading academic institutions like MIT and Harvard and to potential pharmaceutical and biotech partners.  This unique location allows for a high level of energy and intellectual exchange within and among fast growing early stage companies.

What benefits does Unum offer?

To attract the very best talent, we offer a generous benefits package that includes competitive pay, performance-based bonus, stock options, insurance coverage (health, dental, life, and disability), trust-based time-off, a 401(k) plan,and commuter/parking benefits.

How to Apply?

Please send cover letter and resume to: careers@unumrx.com

Unum is an equal opportunity employer.

We are only accepting applications from candidates with authorization to work in the United States at this time.

Note to agencies – we are not accepting unsolicited resumes from agencies and will not be responsible for fees associated with any such submittals.

Associate Scientist, In Vitro Immunology at Unum Therapeutics

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0

Associate Scientist, In Vitro Immunology at Unum Therapeutics

Who are we?

Recent advances in T-cell engineering and antibody therapeutics have led to phenomenal results in treating cancer patients, opening the possibility for combining these powerful therapeutic modalities. Unum Therapeutics aims to transform cancer treatment through the discovery, development, and commercialization of novel cellular immunotherapies.We’re moving forward fast, are you? Visit www.unumrx.com for our latest news!

What are we offering to you?

This is an outstanding opportunity to be a founding member and scientific leader of an early-stage, well funded, start-up company. You will be a vital part of helping to achieve the Unum vision: to transform cancer treatment and deliver patient cures.  Unum is a place where your input matters -- you will have a direct impact on our science and will help to build our capability as a team. You will also shape the Unum culture and be a part of a passionate, transparent, and collaborative work environment.

We are seeking a high-energy, flexible in vitro immunologist to be a key contributor to the in vitro biology efforts at Unum.

What will you be doing?

  • Developing and executing T-cell-based immunological assays like cytotoxicity, proliferation, activation, and cytokine release using a variety of analysis methodologies like flow cytometry, luminescence, and ELISA.
  • Culturing, maintaining, and characterizing primary T-cells and cell lines.
  • Contributing to drug discovery and technology development projects through collaboration across scientific groups at Unum.
  • Contributing to other initiatives as they arise in our fast paced start-up environment.

Who are we seeking?

  • BS with at least 3 years or MS with at least 1 year of relevant experience in an industry (preferred) or academic setting.
  • Experience developing and executing immunological assays with a variety of analysis methodologies (e.g. flow cytometry, MSD, luminescence).
  • Experience culturing, maintaining, and characterizing primary immune cells and cancer cell lines.
  • Experience with T-cell biology and/or cancer biology is a plus.
  • Outstanding written and oral communication skills, and ability to work in a collaborative setting.

Where are we?

Unum is located in a new facility located within walking distance of the Alewife T station in Cambridge, MA. Our space includes an open office layout designed for collaboration and state-of-the-art laboratories. Free access is provided for both on-site parking and gym facilities in the building.  We are in close proximity to leading academic institutions like MIT and Harvard and to potential pharmaceutical and biotech partners.  This unique location allows for a high level of energy and intellectual exchange within and among fast growing early stage companies.

What benefits does Unum offer?

To attract the very best talent, we offer a generous benefits package that includes competitive pay, performance-based bonus, stock options, insurance coverage (health, dental, life, and disability), trust-based time-off, a 401(k) plan,and commuter/parking benefits.

How to Apply?

Please send cover letter and resume to: careers@unumrx.com

Unum is an equal opportunity employer.

We are only accepting applications from candidates with authorization to work in the United States at this time.

Note to agencies – we are not accepting unsolicited resumes from agencies and will not be responsible for fees associated with any such submittals.

Process Development Viral Vector Scientist at Unum Therapeutics

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0

Process Development Viral Vector Scientist at Unum Therapeutics

Who are we?

Recent advances in T-cell engineering and antibody therapeutics have led to phenomenal results in treating cancer patients, opening the possibility for combining these powerful therapeutic modalities. Unum Therapeutics aims to transform cancer treatment through the discovery, development, and commercialization of novel cellular immunotherapies.We’re moving forward fast, are you? Visit www.unumrx.com for our latest news!

What are we offering to you?

This is an outstanding opportunity to be a founding member and scientific leader of an early-stage, well funded, start-up company. You will be a vital part of helping to achieve the Unum vision: to transform cancer treatment and deliver patient cures.  Unum is a place where your input matters -- you will have a direct impact on our science and will help to build our capability as a team. You will also shape the Unum culture and be a part of a passionate, transparent, and collaborative work environment.

What will you be doing?

  • Your main responsibilities will include the development of processes for GMP manufacture of viral vectors used for T-cell therapies. You will create and implement innovative solutions, analyze and interpret experimental process development data, and troubleshoot problems.

  • In developing a manufacturing process you will be responsible for identifying and mapping critical parameters, explore the use of innovative technologies and methods, and adjust processes to optimize performance.

  • You will create and improve SOPs for technology transfer to/from CMOs and collaborators.

  • You will manage and analyze process data from outsourced and in-house manufacturing processes.

  • You will be a valuable contributor to other initiatives as they arise in our fast paced, startup environment.

Who are we seeking?

  • An independent, flexible, high energy expert in viral vector manufacturing for clinical use, with specific past experience with lentivirus and/or retrovirus.

  • PhD with 3+ years of industry experience or comparable experience with viral vector manufacturing.

  • Ability to work flexibly in cross functionally in a startup environment.

  • Specific experience with any of following is beneficial:

    • Manufacture of viral vectors for clinical use

    • Use of viral vectors for transduction, preferably T-cells

    • Purification of viral vectors

    • Knowledge of assays for virus titer, defective particles, transduction efficiency

Where are we?

Unum is located in a new facility located within walking distance of the Alewife T station in Cambridge, MA. Our space includes an open office layout designed for collaboration and state-of-the-art laboratories. Free access is provided for both on-site parking and gym facilities in the building.  We are in close proximity to leading academic institutions like MIT and Harvard and to potential pharmaceutical and biotech partners.  This unique location allows for a high level of energy and intellectual exchange within and among fast growing early stage companies.

What benefits does Unum offer?

To attract the very best talent, we offer a generous benefits package that includes competitive pay, performance-based bonus, stock options, insurance coverage (health, dental, life, and disability), trust-based time-off, a 401(k) plan,and commuter/parking benefits.

How to Apply?

Please send cover letter and resume to: careers@unumrx.com

Unum is an equal opportunity employer.

We are only accepting applications from candidates with authorization to work in the United States at this time.

Note to agencies – we are not accepting unsolicited resumes from agencies and will not be responsible for fees associated with any such submittals.

 

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