Senior Scientist/Study Manager; in vitro Toxicology and Biological Screening

There is an opportunity for an experienced scientist to join our in vitro toxicology/biological screening team based in Watertown, MA.  The successful candidate will be responsible for managing and QC of in vitro toxicology and Bioscience studies.  The role will also encompass line management and training responsibilities in addition to working closely with other teams at additional Cyprotex facilities in the US and UK.

Experience and knowledge

• MS or PhD trained with 3-5 years industry experience in the field of in vitro biology and assay development.
• Ability to work in a fast-paced, team environment with a good appreciation of deadlines and customer service.
• Excellent written and verbal communication skills.
• The ability to make decisions, troubleshoot and work independently.
• Prior experience working in a CRO a plus.

Principal Accountabilities

• To manage internal in vitro biology projects and client studies ensuring all work is performed to a high standard within expected timelines
• To train and develop staff in experimental and scientific processes and provide scientific direction and line management to staff.
• To manage client studies ensuring all information is communicated effectively to laboratory staff, client requirements are followed and data is returned within specified deadlines and provide expert advice and data interpretation
• To lead and drive the implementation, validation, and development of new assay services and technologies.
• To liaise with external customers to co-ordinate transfer of information and compounds between customer and Cyprotex including contracts for existing customers
• To co-ordinate with the other Principal Scientists to ensure consistent and effective management of internal projects, such as assay development, and external studies.
• To support the business development team by acting as scientific advisor in meetings and teleconferences with potential new and existing customers and assist business development in the preparation of protocols and contracts for new customers.
• To assist development of the business in securing new customers by providing high quality science knowledge to potential customers in addition to raising the scientific profile of Cyprotex.

 Skills and Competencies

• In-depth knowledge of High Content Screening (Arrayscan VTI) and other cell based assay platforms
• Some Knowledge of electrophysiology platforms
• Practical experience in Assay Development
• Ability to troubleshoot and find solutions to problems
• Communicates proactively and regularly
• Ability to effectively time manage
• Highly proficient in Microsoft Word, Excel, and other scientific software

Clinical Specialist

Summary:

Vittamed Corporation is a growing international medical device manufacturer focused on the neuro-diagnostic and neuro-monitoring segment.  Headquartered in Lexington, MA, we offer a rewarding work environment with global opportunities while maintaining a small company, employee-focused atmosphere.  We are currently searching for a dynamic Clinical Specialist to join our US office.  This person will report directly to our Chief Medical Officer. The Clinical Specialist will provide demonstrations and training for the use of our products during the pre/post sales cycle, provide on-going customer support, and be involved with various aspects of research and clinical trials.    

Essential Duties and Responsibilities:

• Plan, coordinate, and implement clinical evaluations to optimize acceptance of Vittamed products & technology.
• Work with customers to introduce, promote, and increase the usage of Vittamed products throughout a customer facility.
• Provide installation, related in-service education, and integration to new clients to ensure customer satisfaction.
• Assist with the collection and dissemination of information or feedback provided by customers.
• Evaluate new products or enhancements to Vittamed technology to provide information and feedback to the Product Development.
• Provide product support to users either in person, or by written or verbal means.
• Develop training materials for the Vittamed product line.
• Represent Vittamed at various medical conferences, trade shows or educational meetings
• Assist in research for publications
• Assist in grant application activities – writing, clinical trial design, and management
• Other projects as assigned by Chief Medical Officer to support the team.

Qualifications: 
 
Education & Experience: 

• Bachelors Degree in a clinical/science.
• Five years experience in a clinical discipline, preferably in a discipline that involved patient exposure within multiple in-hospital, clinical areas, such as the ICU, ED, OR and/or medical/surgical patient areas for adult/pediatric patient populations.
• Demonstrate effective educational and presentation skills in diverse settings from one-on-one to formal group situations.
• Clinical research experience and medical report writing (e.g. grant writing)
• Ability to work independently with little or no direct supervision.
• Able to travel a significant portion of the time (in the US and international).
• Advanced MS Office skills to develop effective reports, spreadsheets, and presentations.

Preferred:

• Prior clinical specialist experience – critical care nurse.
• Prior experience intracranial pressure monitoring.
• Clinical experience in adult and pediatric ICU environments
• Ophthalmic technician and knowledge of ultrasound
• Ultrasound technician
• Experience in education within the clinical environment
• Knowledge of patient monitoring and Electronic Medical Records.

Contact:

For additional information about Vittamed, please visit www.vittamed.com

Resumes and cover letters can be sent to mmckeon@vittamed.com

FORMULATION SCIENTIST; PHARMACEUTICALS

 Brief Description of the Position

 In this critical position you will be responsible for all aspects of drug product design (formulation) from lead optimization during drug discovery to late stage clinical development, manufacturing and distribution to clinical trial sites.  The successful candidate will develop and execute formulation strategies (project planning, experimental design, data evaluations, formulation of relevant and scientifically based conclusions) by applying their technical expertise and knowledge of various formulation development approaches for small molecule solid oral dosing forms.  The incumbent will balance internal design effort with initiatives to identify, organize and engage in external collaborations based on current needs. Broad general pharmaceutical product development including fixed combination dosage forms is required. Candidate must have proven ability to meet technology research and development goals on aggressive timelines while having a record of collaboration with quality units and regulatory stakeholders. Experience in translating pre-clinical formulation work, toxicology and clinical feedback into robust dosage form. Regulatory submission is essential, and knowledge of cGMP and other relevant regulation is required.  Experience and knowledge of cross-functional team work and management of contract research and manufacturing organizations will be important considerations.

 Key Requirements:

 Strong knowledge of small molecule drug product development and optimization. 

• Strong fundamental understanding of physical and biopharmaceutical properties and their importance in formulation design.
• Working knowledge and know-how to support preclinical studies with variety of formulation approaches and delivery routes.
• Experience with technologies for solubility/bioavailability enhancement of poorly soluble candidates.
• Ability to identify and manage cGMP drug product manufacture of solid oral dosing forms. 
• Strong knowledge of GMP regulations as well as familiarity with regulatory requirements surrounding import and distribution of investigational medicinal products to overseas trial sites.  
• Ability and willingness to make independent decisions in areas of responsibility. 
• You will need to be able to work in a team environment and respond to multiple client audiences in the preclinical, clinical and regulatory spaces.
• Good communication and interpersonal skills.
• Effective and innovative problem solving skills.

Responsibilities:

 Formulation project leader; works with internal and external audiences to meet agreed upon milestones within established time and budget targets.

• Identifies, manages and contributes to external formulation collaborations.
• Interacts closely with internal R&D groups (safety, toxicology, clinical) and partners in conducting efficacy and formulation studies.
• Contributes to scientific and strategy discussions to advance and enhance product candidates.
• Contributes to relevant sections of domestic and international regulatory filings.
• Manages clinical drug product manufacturing.
• Manages clinical drug product inventory and distribution to domestic and international trial sites.

 Expertise and Skills:

 Strong foundation in chemistry, materials science, pharmaceutical sciences or chemical engineering.

• Experienced in formulating small molecule drug products for oral solid form delivery,
• Experienced project leader with demonstrated ability to lead a team to agreed upon milestones within established time end budget parameters.
• Ability to manage all levels of internal and external clients and interests
• Awareness and understanding of adjacent areas including preclinical and clinical spaces
• Experience with safety regulation and protocols.
• Experience with process engineering and cGMP.
• Experience in clinical trials material manufacturing and distribution.
• Demonstrated ability and willingness to make mission critical decisions on an independent basis
• Demonstrable success in key areas of responsibility

 Education and Experience:

 Ph.D. degree in pharmaceutical sciences or related field with  6 + years of experience and proven track record of success in small molecule formulation, analytical evaluation and related technologies

• Strong foundation in chemistry, materials science, pharmaceutical sciences or chemical engineering
• Experience in the development of fixed combination oral dosage forms would be of exceptional value.
  

About Flatley Discovery Lab

 Flatley Discovery Lab is a privately funded not-for–profit biopharmaceutical company located on the waterfront in Charlestown, MA.  Our sole research focus is the identification and development of small molecule drugs to treat or cure cystic fibrosis.  The company currently has multiple candidates either in or near the clinical trial stage.  FDL is an equal opportunity employer passionately committed to its cause and to the highest levels of quality, integrity, and success.

With our clients expanding biologics pipeline, the process development department is looking to add additional talent to their innovative team.  This position will support all operations in the LSPD lab in all aspects of monoclonal antibody processing, from cell thaw to formulation.   This includes assisting with the passaging of cells and operation of bioreactors up to 250L scale as well as the set up and operation of the downstream unit.
Required Knowledge, Skills and Attributes:
• BS with 1 year of purification / characterization experience
• Knowledge of clarification and purification technologies (Downstream)
• Experience with AKTA skids
• Experience with Unicorn Software a PLUS
• Experience packing 5mm to 30cm columns
• Amazing organizational and communication skills
About StratAcuity
Whether you are seeking a career change or simply interested to become part of our network, you will appreciate the ethics guiding each StratAcuity team member. We build lasting relationships with exceptional scientists and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a StratAcuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.

CHEMISTRY IS EVERYTHING™

CutisPharma is a specialty pharmaceutical company focused on bringing innovation to the pharmaceutical compounding market.   CutisPharma’s FIRST Unit-of-Use compounding kit franchise has provided significant benefits to pharmacists and patients by replacing traditional compounding with standardized kits that are easy to use, save time, and provide consistent quality.    We are seeking a talented and motivated Quality Engineer to join our team.

The Quality Engineer will primarily be responsible for evaluating and assist in developing, as necessary, all quality characteristics of the plant facilities, validation and qualification activities, and equipment quality system (critical systems).  The Quality Engineer will execute and/or coordinate risk and gap assessment analysis to ensure that the plant critical systems and equipment are in a state of control.  The experience candidate will proactively participate in facilities and equipment quality system enhancement projects to decrease the likelihood of action(s) resulting from a regulatory inspection; and will work in partnership with manufacturing operations, research and development, engineering, maintenance and support areas to solve problems and provide expertise on compliance issues and corporate quality policy requirements relating to critical systems.

PRINCIPLE DUTIES AND RESPONSIBILITIES

• Evaluate facilities and equipment quality system.  Quality evaluation of the plant critical systems.
• Approve engineering change control for validated critical equipment and controlled areas which includes preapproving and approving of change controls.
• Provides quality oversight for process equipment qualification and commissioning, and facility commissioning and validation. Approves protocols/validations/qualifications.
• Analyzes data and assist in implementation of both corrective and preventative actions to enhance processes for critical systems and equipment (water, HVAC, powder filling equipment, capper, labeler, etc.).
• Leads and/or coordinates investigations related to critical systems and equipment. CAPA management and root cause analysis.
• Assist in gap analysis, FMEA and/or risk assessments to ensure evaluation of critical systems and equipment are in compliance with all regulatory requirements, e.g., cGMPs, FDA Guidelines, USP, ISPE, ISO etc.
• Interacts with the regulatory officials to convey the compliance level of the facilities and equipment quality system during regulatory inspections.
• Participates in quality projects and teams to implement improvements to the facilities and equipment quality system infrastructure to meet regulatory requirements.
• Provides training to appropriate personnel related to facilities and equipment quality system
• Trends and tracks critical system data as appropriate.
• Provides support to the plant during maintenance activities. 
• Perform other tasks on projects as needed/assigned.

QUALIFICATIONS

• B.S. Degree in engineering or technical science degree.
• Minimum 5 years QA experience in pharmaceutical or other highly regulated industry.
• Working knowledge of cGMP practices.
• Working knowledge of 21 CFR Part 210, 211 and USP, ISPE trends and guidelines.
• Must have experience in qualification and validation practices.
• Requires approximately 10% travel.
• Ability to work in a team environment.

We recognize hard work and dedication with benefit offerings that address individual needs.
Our comprehensive package of benefits for eligible employees includes the following:

• Competitive compensation package as well as bonus incentives for excellent performance
• Competitive medical, dental and vision insurance
• Paid time-off program, Vacation
• Tax-advantaged savings plans [401(k) with match and deferred savings plans]
• Company-paid life insurance
• Anniversary Service Award program

Qualified candidates should submit their resume, statement of interest and salary requirements to careers@cutispharma.com

NO PHONE CALLS PLEASE

CutisPharma, Inc. is an Equal Opportunity Employer

CutisPharma is a specialty pharmaceutical company focused on bringing innovation to the pharmaceutical compounding market.   CutisPharma’s FIRST Unit-of-Use compounding kit franchise has provided significant benefits to pharmacists and patients by replacing traditional compounding with standardized kits that are easy to use, save time, and provide consistent quality.    We are seeking a talented and motivated Senior Compliance Officer to join our team.

The Senior Compliance Officer will support the pharmaceutical manufacturing programs at CutisPharma, as well as Quality for contract manufacturing programs, as necessary.  The Senior Compliance Officer is responsible for developing and ensuring site execution of quality strategies that ensure pharmaceutical product manufactured at CutisPharma are produced in compliance with applicable regulations and corporate quality expectations, and are released in a timely manner to meet production and supply timelines.  The successful candidate will support pharmaceutical manufacturing and the corporate supply chain (manufacturing, packaging, testing and distribution).  The Senior Compliance Officer will develop strategic direction and ensure execution of continuous improvement through idea development, plan creation, implementation, and interaction with team leaders in Operations, Production, Research and Development and Warehousing.  The Senior Compliance Officer will collaborate with the Director, Quality Assurance to ensure the development, implementation and maintenance of GMP quality operations.

PRINCIPLE DUTIES AND RESPONSIBILITIES

• Develop and lead quality operations strategy specific to providing supply chain products that ensure CutisPharma;s quality expectations, minimizes compliance risk, and assures current Good Manufacturing Practice (cGMP) compliance.  Lead internal staff and outsourced personnel/vendors in execution of strategy and identify continuous improvement plans and opportunities.
• Oversee daily GMP quality operations and timely disposition of pharmaceutical manufacturing to support CutisPharma’s supply chain demands, while assuring product quality and compliance.  Develop solutions to complex issues and Quality initiatives with Production and Warehouse team leaders, following cGMP regulations and CutisPharma standards
• Organize and develop timely action plans in close coordination with area leadership, ensuring a seamless execution of successful QA strategies.  Advance GMP QA’s ability to provide support to internal stakeholder strategies based on a thorough understanding of and alignment with key business drivers and company strategy.
• Have strong knowledge and understanding of the broad CutisPharma supply chain.  Identify, understand, analyze, and identify risks and quality issues, and develop mitigation strategies.
• Provide site leadership to ensure timely, well-documented, and compliant resolution of quality issues and implementation of corrective actions that maintain a continual state of regulatory compliance for pharmaceutical manufacturing and development activities.
• Ability to work in a team environment.

QUALIFICATIONS

• Bachelor’s Degree in chemistry, engineering or related field.  Minimum of 10 years pharmaceutical manufacturing and packaging experience including at least 5-7 years in GMP QA/QC/compliance.

• At least 5-7 years of managerial experience in a similar setting.
• Experience in quality assurance of drug product through the lifecycle of pharmaceutical product development.
• Track record of successfully working with and managing third-party vendors.
• Experience applying GMP Quality knowledge through standard operating procedures (SOPs) to facilitate business operations and in some cases, develop procedural solutions to appropriately resolve quality and compliance challenges.
• Experience applying Quality Systems (e.g., change control, deviations, CAPA, complaint management, and documentation management among others).
• Proven experience in leading Pharmaceutical Quality support.
• Experience in production management, specifically in cGMP manufacturing and packaging, highly desirable.
• Experience in equipment commissioning, qualification, process validation and Quality by Design (QbD) experience a plus.
• Experience in corporate integration activities, a plus.
• Requires approximately 10% travel, both domestic and international.

 ADDITIONAL SKILLS

• Superior reasoning and problem solving skills with the ability to exercise sound judgment and make decisions based on accurate and timely analyses.
• Excellent interpersonal, communication and writing skills.
• Ability to effectively present information and respond to questions from Senior Leadership, peers, and external personnel.
• Adept at identifying prospective problem areas and recommending process improvements.
• Ability to manage multiple tasks, meet deadlines, and work under pressure in a fast paced environment. 
• High level of integrity and dependability with a strong sense of urgency and results-orientation.
• Fundamental understanding of pharmaceutical manufacturing and the drug development process, scientific methods and thought.

We recognize hard work and dedication with benefits offerings that address individual needs.
Our comprehensive package of benefits for eligible employees includes the following:

• Competitive compensation package as well as bonus incentives for excellent performance
• Competitive medical, dental and vision insurance
• Paid vacation, sick, holidays and floating holidays
• 401(k) with Company match
• Company-paid life/AD&D and disability insurance
• Anniversary Service Award program

Qualified candidates should submit their resume, statement of interest and salary requirements to careers@cutispharma.com

NO PHONE CALLS PLEASE

Position Description

• Responsible for developing and testing TB assays in a BL2+ lab; aiding in the creation of bacteria specific magnetic particles for the Company’s diagnostic      platform technology as well as processing human clinical samples for  validation of technology.

Required Skills, Knowledge and Experience

• Proactive individual with good communication skills, analytical, organization,      collaboration, communication, problem solving, and general people skills
• Skilled at BL2+/BL3 lab work and Experience in setting up, and maintaining BL2+ lab and lab equipment
• Ability to function autonomously, with minimum handholding and supervision; with an  affinity toward detail while cognizant of “big picture”
• Development  and validation of assays
• Strong  microbiology skills
• Experience  in infectious diseases
• Ability work  in a cross functional team

Minimum Qualifications

• Ph.D. in Microbiology, with minimum  one year experience in TB diagnostics, post-graduate degree or diploma in  T.B/Tuberculosis and Chest diseases.
• M.Sc. with specialization in  Microbiology/ Medical Microbiology/ Applied Microbiology/ Clinical  Microbiology/ Biotechnology/ Medical Biotechnology, with a minimum three  years of work experience, preferably in the field of TB diagnostics;
• Senior Microbiologist: MSc in  Microbiology with PhD. At least three years of experience in a laboratory  performing Mycobacterial culture and DST.
• BL2+/BL3  laboratory experience
• Experience of Rapid TB diagnostics  shall be an advantage.

Specific Key Responsibilities

• Set up and  maintain BL2+ laboratory
• Set up TB assays  and aid in TB antibody conjugation and PCR bio-probe development  for validating company’s platform      technology
• Processing  and testing clinical samples for validation of diagnostic device
• Manage  and/or oversee management of vendor related activities
• Proactively,  and independently, identify and resolve project challenges
• Represent  projects at key meetings

https://home.eease.adp.com/recruit/?id=15040151

https://home.eease.adp.com/recruit/?id=15040171

Peptide Chemist

Ra Pharmaceuticals is a development stage Biotechnology Company with a platform that enables the discovery of novel therapeutics.  Ra Pharma combines novel insights into complement and other innate immunity pathways with leadership in macrocycle technology to transform the lives of patients with life threatening disorders. Our primary clinical focus is on diseases of complement dysregulation and orphan indications defined by validated biomarkers.

Description: 

 We are currently seeking a peptide chemist to join our team.  Primary responsibilities will include the design, synthesis, purification and characterization of peptides using state-of-the-art methods.  Additional responsibilities will include the analysis of biological and physicochemical data and the elucidation of structure-property relationships that will guide optimization of drug candidates.

Qualifications: 

The ideal candidate will have a Ph.D. in chemistry, biochemistry, or a related discipline and 2-5 years of postdoctoral experience.  Demonstrated experience in solution- and solid-phase peptide synthesis including the use of automated peptide synthesizers is required.  Experience in general organic synthesis, peptidomimetic chemistry, structure-based design, and medicinal chemistry is highly desirable.   Candidates should also demonstrate excellent written and oral communication skills, creativity and initiative, and must have the ability to work effectively as part of a multi-disciplinary team.

Associate Scientist/Scientist/Manager Analytical Development -

Ra Pharmaceuticals is a clinical stage Biotechnology Company with a platform that enables the discovery of novel therapeutics.  Ra Pharma combines novel insights into complement and other innate immunity pathways with leadership in macrocycle technology to transform the lives of patients with life threatening disorders. Our primary clinical focus is on diseases of complement dysregulation and orphan indications defined by validated biomarkers.

Description:  We are currently looking for a resourceful and motivated individual to join our team as an Associate Scientist, Scientist or Manager.  This candidate will have a supportive role in Analytical Development by coordinating and potentially supervising outsourced analytical testing, developing analytical methods and generating reports for regulatory filings.  Based upon experience, the candidate may oversee outsourced analytical method development, technical transfers, GMP material release and stability studies.  This person will also be responsible for supporting non-GMP in-house stability studies and materials release and will be expected to contribute to method development by developing and improving assays, reviewing data as well as investigating and troubleshooting assays and equipment issues and recommending improvements.

Qualifications: The ideal candidate will have a PhD or a BS/MS in Analytical Sciences or a closely related field and 2-7+ years of industry experience in analytical development or quality control.  Experience with analytical development for peptides as well as experience in technical transfers and managing stability studies.  Experience with preparing analytical sections of regulatory documents (IND/IMPD) is highly desirable.  The successful candidate must be able to thrive and develop in a dynamic biotechnology start-up environment, to complete tasks with a sense of urgency, and have a passion for scientific excellence.

Requirements:

• BS/MS/PhD in Analytical Sciences or a related field
• 2 to 7 years of industry experience
• Experience with Peptide, small molecule and/or protein analytical and characterization techniques
• Strong understanding of HPLC and UPLC methods (reverse phase, size exclusion, ion exchange)
• General familiarity with USP and EP compendial methods
• Driven to solve problems and able to work independently
• Possess excellent communication skills

To apply, please send your resume and cover letter to hr@rapharma.com.

Our client, an innovative company located in Cambridge MA with a focus in developing novel, targeted drugs for the treatment of cancer, is seeking multiple positions focused in both Analytical Development, from the Senior Manager to Director level. This is an extremely unique opportunity to be a part of an emerging virtual company that is currently in early to late-stage clinical trials – great growth is possible for what will be a quickly growing start-up.

Our client is building out a Technical Operations team, so experience in working with external vendors of multiple programs is essential, as is experience in working with monoclonal antibody programs.

Our client will consider candidates at a BS/MS level, or an exceptional PhD candidate for a leadership opportunity with the group.  Experience interacting with or indirectly supervising a Quality Control organization would be a plus for the senior level hire, as would previous close interaction with Regulatory and Quality Assurance to ensure proper documentation and following of FDA regulations. 

A forward thinker with excellent interpersonal skills and a team player mentality with the ability to act as a spokesperson, consultant or advisor to top management on corporate research and development direction will fit best in this role.  

About StratAcuity
Whether you are seeking a career change or simply interested to become part of our network, you will appreciate the ethics guiding each StratAcuity team member. We build lasting relationships with exceptional scientists and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a StratAcuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.

CHEMISTRY IS EVERYTHING™

Responsibilities

BASIC SUMMARY:

Responsible for leading revenue recognition initiatives and optimization of processes and procedures. Ensure compliance to the FASB’s revenue recognition standard.

Qualifications

Equal Employment Opportunity

Charles River Laboratories, Inc. is an Equal Opportunity Employer M/F/Disabled/Vet

Agenus is seeking an experienced, energetic toxicologist to lead and manage nonclinical safety programs for a variety of monoclonal antibodies, therapeutic vaccines and other novel biologic modalities.

The position would suit an enthusiastic and inquisitive toxicology scientist who has strong practical experience of the nonclinical safety assessment of biologics and also has a keen interest in cutting edge immuno-oncology research. The position requires someone with strong self-motivation and initiative that thrives in a high caliber science and entrepreneurial environment. There is much opportunity to become a key member of an exciting and expanding biotechnology company with a passion for delivering novel medicines to patients.

Lead and manage nonclinical safety programs for a variety of monoclonal antibodies, therapeutic vaccines and other novel biologic modalities.

Provide strategic advice to project teams on early program (target liability assessment) and later stage needs. Design appropriate nonclinical development plans and studies required to support IND programs and in later stages of clinical development. Monitor studies at CROs and ensure operational timeliness, high quality data interpretation and reporting. Use toxicology and scientific expertise to shape and enhance early stage scientific direction as well as resolve any mechanistic issues.

Ensure nonclinical risk assessments are clearly presented in reports and regulatory documents, and that they reflect an accurate and well integrated assessment of the relevant data and interpretations.

Help to develop and manage the operational and scientific aspects of the overall CRO and consultant network strategy.

PhD in toxicology or a related biological science discipline.

DABT preferred.

10 years of experience as a toxicologist in a Pharma/Biotech/CRO environment, with direct experience working successfully with R&D teams and regulatory agencies.

Biologics development experience essential.

Experience developing and managing nonclinical safety plans from target selection through FIH and clinical development phases.

Experience interacting and communicating effectively with research scientists, multi-disciplinary project teams, management, external consultants and CROs, and regulatory bodies.

Experience reviewing and interpreting data, writing reports and preparing high quality regulatory documents.

Demonstrated high organizational skills with the ability to operate effectively in a fast-paced and matrixed environment.

Experience in immuno-oncology programs preferred.

Working knowledge of pharmacokinetics/toxicokinetics.

GENERAL SUMMARY OF POSITION:

Under the general direction of the Director or designee, the Associate Director Process Development is responsible for leading Process Development analytical activities. This position provides technical guidance and leadership to Process Development staff; manages downstream process development projects; prioritizes group tasks and manages resources in order to meet organizational and departmental goals.

MAJOR RESPONSIBILITIES:

• Develop and troubleshoot assays for characterization of MAb and vaccine products.
• Conduct preclinical stability studies and characterize degradation pathways.
• Support upstream and downstream development with spent medium analysis and testing of in-process material.
• Ensure accurate and complete documentation of laboratory activities, suitable for regulatory submissions.
• Write technical reports for tech transfer and regulatory submission.
• Lead the investigation and development of biochemical or biophysical assays that will be used in MAb formulation development, stability studies, and in-depth characterization of purified products.
• Collaborate with and support Product Discovery, Quality Control and other groups within the organization to meet organizational objectives.
• Provide technical and scientific guidance to team members.
• Maintain substantial current knowledge of new analytical technologies and innovations that could be applied to MAb characterization.
• Work with senior leadership team to maintain an environment that fosters teamwork, collaboration, and innovation.
• Hire, manages and trains staff. Plans and assigns duties to meet departmental and organizational objectives. Provide guidance and direction to staff; establishes expectations, defining roles, supporting career development and managing performance.
• Work on problems of diverse scope where analysis of situation or data requires a review of complex data.
• Perform additional job related duties as required.

REQUIRED QUALIFICATIONS:

• Requires a PhD in a relevant scientific discipline such as Chemical Engineering, Biochemistry, Molecular Biology, or other relevant field and a minimum of 5 years of relevant experience.
• Demonstrated technical proficiency, scientific creativity, collaboration with others, and independent thought. Solid knowledge on scientific principles and concepts.
• Must have strong verbal and written communication skills. Ability to communicate effectively with others internally (up, down, and laterally) and externally to the organization.
• Demonstrated ability to manage and prioritize multiple projects and consistently meet deadlines.
• Possesses strong attention to detail, the ability to maintain accurate records and excellent proofreading skills
• Excellent problem solving skills as well as time management and organizational skills.
• Proven ability to manage others, assign and schedule work, and conduct performance evaluations.
• Able to travel as needed

PREFERRED QUALIFICATIONS:

• Previous experience in a cGMP environment
• Experience with Design of Experiment (DOE) software

Apply Here

PI92572358

Metrum Research Group is looking for a research scientist to join our modeling and simulation team. Locations in Wellesley, MA and Tariffville, CT. Apply today!

Duties: Conduct modeling and simulation to support drug development decision-making. Perform population phar- macokinetic (PK) pharmacodynamics (PD) analysis, exposure-response modeling, and trial simulation using soft- ware NONMEM and R. Perform model-based meta-analysis in certain therapeutic area. Conduct Bayesian data analysis using software packages of WinBUGS, OpenBUGS and JAGS. Perform quality control on PK/PD models and R scripts. Requires advanced knowledge of pharmacometrics, PK, and population PK; must be familiar with population PK/PD modeling using NONMEM and R; knowledge of Bayesian data analysis using WinBUGS, OpenBUGS and JAGS; good understanding of statistical analysis in longitudinal, correlated and categorical data.

Requirements: PhD Degree in Experimental and Clinical Pharmacology, Pharmacokinetics, or related field is required.

Metrum Research Group, established in 2004, is a global leader in biomedical modeling and simulation. We have provided strategic decision making for more than 100 companies on over 250 projects. At Metrum Research Group we support our clients in advancing drug development programs by supplying them with the highest quality scientific expertise. Please send resume and a brief cover letter in the body of an email. We prefer to hear directly from candidates. No recruiters please.

Metrum Research Group is an equal opportunity employer.

Cerulean Pharma

Business Development Internship

Duration 3-4 months; 20+ hrs/week

Start Date: Immediate

Cerulean is looking for a highly-motivated intern to support the business development activities of a public (Nasdaq: CERU), oncology-focused biotechnology company.  This position reports to the Director of Business Development.

Description:

Assist with business development activities, including maintenance and creation of PowerPoint slide presentations to be used in BD meetings, modeling strategic transactions and assisting with analysis of deal trends in the biopharma space. Perform detailed scientific review, market research and/or oncology product pipeline analysis to arrive at recommendations for senior management. Present findings to the business development group, and assist in developing meeting materials for use in business development discussions.

A competitive candidate would be an undergraduate in Biology or pre-med student who is interested in exploring the business and finance side of Pharma/Biotech; conversely, an Econ or Business/Finance student with a demonstrated interest in biotech could also be a strong fit. Experience and working knowledge of Excel and PowerPoint is required. Interest or experience in biopharma strategy is preferred, as is knowledge of basic epidemiology and the drug approval process.

Contact:

Andres Tellez

atellez@ceruleanrx.com

Responsibilities

BASIC SUMMARY:

Responsible for researching technical accounting matters and developing policies to support compliance with regulatory standards.

Qualifications

Equal Employment Opportunity

Charles River Laboratories, Inc. is an Equal Opportunity Employer M/F/Disabled/Vet

Responsibilities

BASIC SUMMARY:

Responsible for analyzing and communicating global financial statement information. Work closely with site, business and corporate financial management to ensure compliance with company and accounting policies and procedures.

Qualifications

Equal Employment Opportunity

Charles River Laboratories, Inc. is an Equal Opportunity Employer M/F/Disabled/Vet

Responsibilities

Fluency in Mandarin preferred

BASIC SUMMARY:

Provides a basis for management planning, operating controls and financial performance appraisal.

ESSENTIAL DUTIES AND RESPONSIBILITIES:•Plans and conducts complex studies to determine cost of business activities. Recommends budget adjustments, and other cost improvement measures. •Analyzes complex financial data and extracts and defines relevant information; interprets data for the purpose of determining past financial performance and/or to project a financial probability. •Reviews costs and performs cost benefit analysis related to projects and/or programs. •Performs complex statistical, cost and financial analysis of data. •Develops financial reports for forecasting, trending and results analysis. •Interprets financial transactions in order for Sr. Management to make economic or business decisions. •Supports the execution of the strategic planning and forecasting process. •Prepares materials for presentation. •Assist in the development of management reporting and planning systems and tools. •Ensures SOX and other regulatory compliance. •Supervises staff •Perform all other related duties as assigned.

Qualifications

•Education: Bachelor’s degree (B.A. /B.S.) or equivalent in Accounting or Finance or related discipline. •Experience: Five to seven years related experience and/or training. •An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above. •Certification: MBA, CPA or CMA designation desired. •Other: Excellent spreadsheet skills required. Fluency in Mandarin preferred.

Equal Employment Opportunity

Charles River Laboratories, Inc. is an Equal Opportunity Employer M/F/Disabled/Vet