Alcresta is a specialty pharmaceutical company that is developing innovative and proprietary enzyme based products for people suffering from compromised pancreatic function such as exocrine pancreatic insufficiency (EPI) or nutrient malabsorption.  

Senior Accountant

Summary: Reporting to the Director of Finance, the Senior Accountant will play a key role in the monthly and year-end closing cycle, help to upgrade our ERP, work closely with our auditors, maintain and develop financial control. 

Responsibilities: 

• Prepare journal entries and handle accounts payables
• Lead monthly/Quarterly closings. 
• Drive annual audit process.
• Interface with management and vendor reporting systems regarding the management of inventory levels, revenue reporting, Accounts Receivables reporting through our 3PL.
• Corporate and Management Reporting
• Ad hoc projects as assigned.  

Qualifications

• Bachelors Degree in Accounting or Finance
• Proficient in Excel and PowerPoint
• Good communications skills
• Self motivated individual, willing to grow with company that is just entering the commercial sales phase. 

Salary commensurate with experience. 

Please send cover letter and cv to hr@alcresta.com

Summary

Ensure that Pharmalucence pharmaceutical products meet specific quality standards through the effective evaluation, validation and documentation of activities related to the microbiological aspects of the manufacture and testing of Pharmalucence products

Responsibilities and Tasks

Execute all activities in compliance with current Good Manufacturing Practices (cGMPs), Good Laboratory Practices (GLP) and ISO Quality Assurance Procedures and Pharmalucence policies and procedures. Work under minimal supervision using Standard Operating Procedures and own judgment to effectively coordinate and execute assigned activities in support of production, Quality Control and Research and Development activities. Support assists environmental monitoring and personnel qualification programs (gowning). Review and trend microbial identification data. Review environmental and utility monitoring data and generate periodic trend and recovery reports from that data. Review data from routine and non-routine surveys, test procedures, method suitability protocols and reports abnormalities to management in a timely manner. Perform root cause investigations for environmental and utility monitoring and product/raw material testing. Performs root cause investigations related to deviations that occur during operations in the Microbiology Department. Author and execute Corrective and Preventive Action plans as required. Author change controls related to microbiology operations as required. Provide monthly department metrics to Senior Quality Mangement.   Provide back-up microbiological support for the QC, Production and R & D groups. Provide microbiological technical support to QC, QA to address customer requests. Author, review, and revise microbiology related Standard Operating Procedures. Train personnel on microbiological related SOP’s and technological upgrades. Perform internal and external microbiology cGMP audits as required. Provide support and direction to QA and QC Microbiology personnel.

Knowledge Skills and Abilities

Excellent verbal, written and interpersonal communication skills Knowledge of microbiology (industrial), environmental monitoring and aseptic techniques Knowledge of cGMP and GLP, FDA/USP requirements Sterility testing and Endotoxin assays and validation Microbiological limits testing Knowledge of USP and EP/BP method/validation Regulations Microbiological identification methods Working knowledge of lab equipment including Autoclaves, depyrogenation ovens, filtration equipment, heat blocks, incubators, microscopes, cameras, Laminar Flow Hoods, Biological Safety Hoods, UV-lights and meters, centrifugal air samplers, particle counters, radio survey equipment, validation equipment Computer/office machines

Education and Experience

BS required in related scientific field Minimum

6-8 years related experience preferred

Pharmalucence is an Equal Opportunity Employer

Individuals with Disabilities and Protected Veterans are encouraged to apply.

If you need help applying online, please contact joyce.robbins@sunpharma.com or call

Joyce, HR Assistant at 781-275-7120

Duties:
Using eCTD Manager or sCubed or Insight applications, this position will be responsible for managing publishing tasks associated with the compilation and dispatch of NDA, BLA, and IND type submissions as well as all associated regulatory transactions to North American Regulatory Agencies.
Publishing responsibilities include Modules 1 through 5 and all associated regulatory transactions to FDA such as ESG Gateway.
This position will maintain effective interactions with Regulatory Clients to ensure priority conflicts and deviations from the plan are resolved to minimize impact on submission dates and ensure on-time submissions. This position will be responsible for the coordination of publishing tasks associated with the assigned submission, including initial quality control of submissions generated by other Global Publishers.
Skills:
Four years’ experience in submission publishing using eCTD Manager, sCubed or similar eCTD building tools. This position will be responsible for managing publishing tasks associated with the compilation and dispatch of NDA, BLA and IND type submissions as well as all associated regulatory transactions to North American Regulatory Agencies.

Thorough knowledge of the content and organization of regulatory submissions required.
Experienced with regulatory submissions publishing and electronic review aids and understanding of application of technologies

Experienced in use of DMS, MS Office tools, ISI Toolbox, and eCTD build tools

Demonstrated regulatory knowledge and awareness, technical competence, sound judgment, and a professional demeanor

Demonstrated leadership and flexibility in dealing with change and diversity

All candidates should have an understanding of the concepts around regulatory affairs and significant knowledge of submissions processes. Thorough knowledge of U.S. FDA Regulations and ICH Guidance’s as they apply to the creation of investigational drug (IND and IDE) and marketing (NDA, BLA, and Device) applications.

Demonstrated ability to work in a technical environment required.
Strong communication and organizational skills required. Task planning and coordination skills required. Ability to multi-task, work well under pressure and time constraints is essential.

Requirements
Education/Experience:
Experience utilizing eCTD Manager.
Experience utilizing Insight Publishing Suite.
Experience using sCubed.
Experience in publishing MS Word documents.

Position Summary
The candidate will be responsible for supporting the operational, planning, and decision-making processes within Client's Early / Global Development Teams (E/GDT). They work closely with the Program Manager supporting the person responsible for overall team leadership to ensure robust and balanced cross-functional planning, decision-making, implementation, monitoring, and reporting of the E/GDT(s) for multiple related programs to ensure strong alignment between Product, Lifecycle strategy (if applicable) and operational execution by the E/GDTs. The program manager also works to ensure the cross-functional teams operate effectively with positive team dynamics.

Requirements
The candidate must have previous experience in project and program management for drug development projects. Experience working with cross functional Pharmaceutical R&D teams focused on Phase 1-3 trials is required.

Our client is seeking to hire strong Pharmacology RA’s to help advance pre-clinical development projects.

Main responsibilities include:

• In-vivo based experiments from start to finish under guidance of leadership
• Dosing of rat and mice by multiple routes (po, iv, ip, sc including iv infusion)
• Blood collection including cardiac puncture, vena cava, retro-orbital and jugular vein
• Perform rodent necropsy and tissue collection
• Collect physical data on both rats and mice Interpretation of toxicological data and ability to write reports
• Use of statistical based software to capture animal data in a quality manner

Requirements:

• BS or MS in a scientific field with 2 to 4 years relevant experience
• Experience working with both rats and mice
• Excellent documentation and laboratory notebook skills.
• Understanding of regulatory requirements and AALAS certification is a plus.
• Proficient with Microsoft Office suite (including Excel, Word and PowerPoint)

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™

Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines for the treatment of central nervous system (CNS) diseases. The company has a diversified commercial product portfolio and a substantial clinical pipeline of product candidates for chronic diseases that include schizophrenia, depression, addiction and multiple sclerosis. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes’ website at www.alkermes.com.

POSITION SUMMARY:

Talent Acquisition

• Perform relocation services for new hires to the Waltham site and field employees.
• Monitor current OFCCP requirements and ensure proper compliance.
• Maintain recruitment processes and programs to provide a consistent experience throughout the organization.
• Manage immigration program including contact with external counsel for new hires and active Alkermes employees
• Staffing lead for Applicant Tracking System, Background Check, and Employment Advertising RFP’s
• Partner with IT and HRIS for the delivery of critical Staffing metrics, projects and reports for HR and Talent Acquisition.

Operations/HRIS Support

• FLSA, EEO, accuracy of HR Data
• Ensure compliance with all state and federal HR laws
• Develops, supports, and communicates policies and procedures. Manage risk and ensure legal compliance by keeping current with the regulatory environment.
• Annually train employees, staff and managers on employment policies.
• Manage I-9 files
• Ad-hoc reporting, analysis, and special projects and initiatives (Total Rewards, Workforce Analytics and Employee Handbook)

Education & Experience Requirements

• Bachelor’s Degree in Human Resources or related field and 4-6 years of Corporate HR experience including Immigration, Compliance, and current EEO and OFCCP regulations is required
• Experience with Oracle EBS or related HR Enterprise system is required
• Experience with Taleo Business Addition or related ATS is preferred
• Experience in the pharmaceutical/biotechnology industry is preferred
• Excellent consultative, strategic thinking, problem solving, and interpersonal skills
• Strong communication skills, both verbal and written
• Ability to prioritize and work on multiple projects at a time; and the ability to work on many projects with a sense of urgency without sacrificing quality.

Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.

Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines for the treatment of central nervous system (CNS) diseases. The company has a diversified commercial product portfolio and a substantial clinical pipeline of product candidates for chronic diseases that include schizophrenia, depression, addiction and multiple sclerosis. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes’ website at www.alkermes.com.

Essential Areas of Responsibility:

The candidate will conduct lab-based research to support non-clinical drug discovery across a wide variety of disease indications as part of the Biology department.  The candidate is expected to function independently, designing and executing mechanistic pharmacology research projects in the areas of central nervous system (CNS) and peripheral nervous system (PNS) biology.  The applicant will be expected to participate in team based in-vivo testing of the pharmacodynamic effects of potential drug candidates in support of non-clinical drug discovery and will be expected to work collaboratively with others across multiple disciplines. 

In addition to their lab-based responsibilities, the candidate will be expected to:

1) maintain a working knowledge of current experimental techniques and theories in their scientific specialty in order to apply these principles to the development of inventions, products, and areas of research that align with company goals and interests;

2) conceive novel research studies to support the generation of intellectual property;

3) support discovery project team activities;

4) present scientific data at national and international scientific meetings;

5) write scientific manuscripts in support of development activities.  Will be expected to work collaboratively with others across multiple disciplines.

Minimum Education & Experience Requirements:

Ph.D (with 5+ years of post-doctoral or industry experience) in biology, pharmacology, neuroscience or related fields. Extensive hands-on experience with rodent models of neurochemistry, pain, affective disorders and/or metabolic dysfunction (ie.) is required. Expertise in in-vitro pharmacology and pharmacokinetics is preferred.   Proficient with MS Word, Excel, PowerPoint, and GraphPad Prism is also required.   Knowledge of appropriate experimental design and statistical analysis is a must. 

Knowledge/Skills Needed:

Extensive experience with rodent handling, drug administration, general surgical and ex-vivo techniques and multiple in-vivo models of affective disorders, pain/ analgesia or metabolic dysfunction are necessary. The ability to work well with others for the good of the team in order to accomplish specific goals and to effectively communicate with project team members and managers is essential. Good presentation and oral/written communication skills which will be applied to presentations, technical writing, notebook organization, manuscript preparation and statistical applications is needed. The successful candidate will be highly motivated to drive our science forward, acquire new techniques and procedures, and able to effectively perform in diverse CNS  therapeutic areas.

Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.

The Epigenetics Group is seeking a scientist who is passionate about leveraging computational biology to create life-changing therapies for patients with degenerative diseases. You will work within Epigenetics and collaboratively with other company discovery, translational and clinical scientists to design experiments that probe multiple ‘omic dimensions (e.g., transcriptome, proteome, genome, epigenome), to use creative analytical approaches to reveal drug targets and biomarkers, and to generate insights into mechanisms of action. You will become expert in the interrogation of bench- and patient-derived high-throughput data sets to produce new insights into fundamental biology and to further the development of effective therapies.

Requirements
Qualifications:
• Experience and strong proficiency in the analysis and integration of multiple ‘omic data sets
• Familiarity with high-throughput platforms for analysis of: coding and non-coding transcriptomes; DNA, histone, and protein methylation; chromatin conformation; protein/RNA/DNA interactions; and/or genomics, epigenomics, or metabolomics.
• A track record of working collaboratively with teams involved in large-scale data processing and analysis architectures, balancing publicly available toolsets and datasets with targeted internal code development and experimentation.
• A demonstrated understanding of the use of visual information techniques to effectively communicate the essence of complex biological results.
• Knowledge of modern object-oriented and statistical programming techniques, and languages (e.g., R, Python, MATLAB, Java, C/C++, sh).
• Knowledge of current NGS analysis algorithms and toolsets (e.g., STAR, Trinity, Tuxedo, HOMER, MACS, GATK, Galaxy), and comfort using local and cloud-based UNIX compute environments.
• A strong background in statistics and/or machine learning, and knowledge of modern pathway discovery and network analysis techniques.
• A strong record of collaboration with cross-functional, multidisciplinary teams.
• Highly self-motivated with excellent organizational, oral and written communication skills.
Education:
A B.S. plus five years experience, or an M.S. plus three years experience in life science research, with a degree in cell biology, molecular genetics or a related discipline (background flexible). Industry experience a plus.
Candidates with PhD's may also be considered.
• Experimental design, implementation and interpretation skills
• Communication skills
• Creative/innovative/problem-solving
• Adaptable/flexible/agile/team-oriented

www.genocea.com

Genocea Biosciences is a small fast-growing vaccine discovery and development company based in Cambridge, Massachusetts. Genocea is harnessing the power of T cell immunity to develop the next generation of vaccines and immunotherapies. 

Purchasing Administrator (Part-Time, 24-30 hours)

Position Summary

We are looking for part-time purchasing administrator to support the procurement process in a fast paced biotechnology company. The right candidate will have experience with NetSuite; be responsible for the ordering of materials, supplies, and/or equipment; follow through with vendors on shipment and delivery. The candidate will interact with the scientific and administrative staff and process requests in a timely manner.

Primary responsibilities

• Place and process orders
• Reconcile receipt of materials with purchase orders
• Participate in researching and negotiating repetitive purchases.
• Coordinating with suppliers on contracts and reorders of goods and services.
• Monitoring usage history of goods & inventory stock items in coordination with Laboratory Operations staff
• Maintain inventory for office supplies
• Ensure the details of purchase transactions are carried out in a timely fashion
• Follow up on orders to ensure that materials are shipped and delivered on promised dates.

Required Skills

• Have previous procurement process experience and be accustomed to using a computerized system for processing purchase orders
• Be skilled at using Microsoft Excel, Word and PowerPoint
• Demonstrate clear and professional verbal and written communication
• Work and communicate effectively in a matrix environment
• Be detail oriented and possess excellent organizational skills

 Education and Experience

A BS or HS diploma with at least 2 years purchasing experience is required. Experience in the biotechnology field and familiarity with NetSuite or other purchasing software is a plus.

To apply for this position, please CLICK HERE

Research Scientist / Senior Research Scientist / Bioengineer

Cellular Delivery

Job Description

Semma Therapeutics, a recently founded biotechnology company focused on developing a stem cell-based cell therapy for Type 1 diabetes, is seeking a scientist to join its growing team.  The full-time role will focus on developing, evaluating, and fabricating novel biomaterials for use in encapsulation systems that enable clinical evaluation of Semma’s core cell technology.  The candidate will have a strong background in biomedical and chemical engineering, and will possess micro- and / or nano-fabrication skillsets to be used in developing processes used in the manufacture of implantable devices.  A working knowledge of GLP / GMP systems is desired but not an absolute requirement. 

Under the supervision of senior scientists, the scientist will also be expected to play an integral role in chemical and functional characterization of biomaterials, fabrication and design of novel device components, compatibility assessment of material interfaces with pancreatic tissue, and managing various aspects of outside collaborations.   The position will be located in Providence, RI.

Required qualifications

• PhD in biomedical engineering, chemical engineering, or related discipline with at least 3 years of industry experience. 
• Experience with NMR, DSC, GPC, FTIR, SEM, or XPS
• Chemical modifications of biomaterials, including manipulating and measuring surface chemistry profiles. 
• Demonstrated capability in planning, executing, and analyzing experiments
• Able to troubleshoot, solve difficult problems, and develop process improvements
• Attention to detail and careful record-keeping
• Excellent organizational skills and ability to manage multiple projects
• Excellent oral and written communication skills, able to write technical reports and protocols
• Flexible team player excited to collaborate with internal and external partners
• Highly self-motivated
• Flexibility in working schedule to accommodate weekend work

Preferred qualifications

• Experience in evaluating biomaterials in animal models
• Previous experience and knowledge of pancreatic islet biology and diabetes
• Prior industrial experience in a cleanroom environment, most preferably in GMP device manufacturing

Please contact careers@semma-tx.com to share your resume and learn more. 

Research Scientist / Senior Research Scientist / Bioengineer

Cellular Delivery

Job Description

Semma Therapeutics, a recently founded biotechnology company focused on developing a stem cell-based cell therapy for Type 1 diabetes, is seeking a scientist to join its growing team.  The full-time role will focus on developing, evaluating, and fabricating novel biomaterials for use in encapsulation systems that enable clinical evaluation of Semma’s core cell technology.  The candidate will have a strong background in biomedical and chemical engineering, and will possess micro- and / or nano-fabrication skillsets to be used in developing processes used in the manufacture of implantable devices.  A working knowledge of GLP / GMP systems is desired but not an absolute requirement. 

Under the supervision of senior scientists, the scientist will also be expected to play an integral role in chemical and functional characterization of biomaterials, fabrication and design of novel device components, compatibility assessment of material interfaces with pancreatic tissue, and managing various aspects of outside collaborations.   The position will be located in Providence, RI.

Required qualifications

• PhD in biomedical engineering, chemical engineering, or related discipline with at least 3 years of industry experience. 
• Experience with NMR, DSC, GPC, FTIR, SEM, or XPS
• Chemical modifications of biomaterials, including manipulating and measuring surface chemistry profiles. 
• Demonstrated capability in planning, executing, and analyzing experiments
• Able to troubleshoot, solve difficult problems, and develop process improvements
• Attention to detail and careful record-keeping
• Excellent organizational skills and ability to manage multiple projects
• Excellent oral and written communication skills, able to write technical reports and protocols
• Flexible team player excited to collaborate with internal and external partners
• Highly self-motivated
• Flexibility in working schedule to accommodate weekend work

Preferred qualifications

• Experience in evaluating biomaterials in animal models
• Previous experience and knowledge of pancreatic islet biology and diabetes
• Prior industrial experience in a cleanroom environment, most preferably in GMP device manufacturing

Please contact careers@semma-tx.com to share your resume and learn more. 

Research Associate / Senior Research Associate / Scientist

In Vivo Pharmacology

Job Description

Semma Therapeutics, a recently founded biotechnology company focused on developing a stem cell-based cell therapy for Type 1 diabetes, is seeking a scientist to join its growing team.  The full-time role will focus on development of small and large animal models to support functional evaluation of Semma’s core stem cell technology.  The candidate will have a strong background in small animal model development, preferably with a background in initiating, maintaining, and evaluating diabetic animal models, and will be skilled in small animal anesthesia, surgery, blood collection, husbandry, perfusion, and necropsy.  A working knowledge of managing and documenting GLP pharmacokinetic / toxicology studies for the FDA is desired but not an absolute requirement. 

Under the supervision of senior scientists, the scientist will also be expected to play an integral role in authoring of SOPs, interfacing with external laboratories for histology processing and blood chemistry analysis.  The position will be located in Providence, RI.

Required qualifications

• BS or MS in animal science, biology, or associate degree with at least 3 years of relevant experience.  PhD-level candidates considered in certain cases. 
• Experience with managing large-scale animal studies.
• Experience in small animal surgery and various methods of blood collection. 
• Able to troubleshoot, solve difficult problems, and develop process improvements
• Attention to detail and careful record-keeping
• Excellent organizational skills and ability to manage multiple projects
• Excellent oral and written communication skills, able to write technical reports and protocols
• Flexible team player excited to collaborate with internal and external partners
• Highly self-motivated
• Flexibility in working schedule to accommodate weekend work

Preferred qualifications

• Experience in evaluating biomaterials in animal models
• Histological processing in paraffin and plastics
• GLP PK/Tox
• Large animal experience

Please contact careers@semma-tx.com to share your resume and learn more. 

Research Associate/Senior Research Associate/Scientist

Stem Cell/Cell Biology

Job Description

Semma Therapeutics, a recently founded biotechnology company focused on developing a stem cell-based cell therapy for Type 1 diabetes, is seeking an outstanding researcher to join its growing team.  The full-time role will focus on tissue culture and cell biology (stem cell differentiation into pancreatic tissue, and related assays.) Under the supervision of Senior Scientists, the scientist will be responsible for the production and characterization of consistently high quality differentiated cells using standard operating protocols. He/She will also be expected to play integral role in managing various aspect of lab operation, including but not limited to, equipment/consumable purchasing, reagent inventory and equipment maintenance, etc. The position will be located in Cambridge/Boston, MA.

Required qualifications

• MS or BSc in biology, cell biology, tissue engineering or related discipline. 2-3 years of related work experience for BSc candidate will be desirable.
• High level of experience with cell culture, cell-based assays, and cell culture process development
• Demonstrated capability in planning, executing, and analyzing experiments
• Able to troubleshoot, solve difficult problems, and develop process improvements
• Attention to detail and careful record-keeping
• Excellent organizational skills and ability to manage multiple projects
• Excellent oral and written communication skills, able to write technical reports and protocols
• Flexible team player excited to collaborate with internal and external partners
• Highly self-motivated
• Flexibility in working schedule to accommodate weekend work if necessary.
• Authorized to legally work in US.

Preferred qualifications

• Experience with embryonic or induced pluripotent stem cell culture, suspension culture or large-scale culture
• Previous experience and knowledge of pancreatic islet biology and diabetes
• Prior industrial experience in cell culture process development

Please contact careers@semma-tx.com to share your resume and learn more. 

RA / Sr. RA / Scientist - Assay Development & Histology

Research Associate/Senior Research Associate/Scientist

Assay Development & Histology

Job Description

Semma Therapeutics, a biotechnology company focused on developing a stem cell-based cell therapy for Type 1 diabetes, is seeking an outstanding RA/SRA/scientist to join its growing team. The role is ideal for an individual with outstanding skills on Histology and method development of IHC/IF/FC/Q-PCR. Under the supervision of senior scientists, he/she will be responsible for conducting experiments using assays in development along with standard operating protocols. He/She will also be expected to play an integral role in managing aspects of lab operations, including but not limited to equipment/consumable purchasing. The position will be ultimately located in Kendall Square, Cambridge, MA after 1/1/2016.

Essential duties and responsibilities include but are not limited to the following:

• Direct experience in developing immunohistochemistry and immunofluorescence assays

• Hands on experience with all histological aspects including tissue processing, embedding, microtomy, staining etc.

• Experienced with molecular biology (DNA/RNA handling, gene expression analysis and Q-PCR)

• Competent using flow cytometry, ELISA, Western Blotting; knowledge of apoptosis assays

• Proficient in imaging cells and tissue samples using BF and fluorescence microscopy

• Assist senior scientists with assay tech transfer to collaborators and CROs

• Organize and compile results for presentations to internal groups

• Careful record keeping, making precise entries for electronic lab notebook (ELN)

Experience and Required Qualifications:

• BSc/MS in Biological Sciences, Pharmacology or related discipline; 4 years at least of relevant research experience for BSc candidate is desired.

• Highly self-motivated, with attention to detail

• Excellent organizational skills and ability to manage multiple projects

• Team player excited to collaborate with internal and external partners

• Flexibility in working schedule to accommodate weekend work

• Demonstrated capability in planning, executing, troubleshooting and analyzing experiments

Preferred qualifications:

• Prior experience in assay development in industry is a strong plus

• Previous experience with stem cells and knowledge of pancreatic islet biology and diabetes

• A strong applicant will also have experience with gene expression and exposure to Nanostring nCounter platform

Applicants should have authorization to work in the United States. Semma offers competitive pay, health insurance, time-off among other benefits. Please, contact careers@semma-tx.com to share your resume.

Primary Role
• The Product Strategy Program Manager (PSPM), working collaboratively with the Product Strategy Team Leader (PSTL) is responsible for leading the translation of BU/Product Strategy into clear and actionable plans to effectively drive Product Strategy Team (PST) performance.
• The PSPM will also actively work with the PSTL to manage and influence the operational, planning and decision-making aspects of the PST to ensure strong alignment between BU/ Product/ Lifecycle strategy and operational execution (the latter via close interaction with PST- aligned Global Development Team and other PST-aligned Project Teams). The PSPM will measure and report progress towards plan.
• Additional responsibilities may include acting as a BU Business Partner, providing direct leadership and planning support to the BU Head and other functional leaders to develop and disseminate key strategic, financial and product related deliverables, including cross- PST/cross-BU initiatives.

Responsibilities
90%
PST Operations / Program Management
• Working independently, and without routine management supervision, provide best in class operations and program management
expertise to drive PST members towards excellence in execution.
• Develop, maintain and track robust, cross-functionally aligned and integrated (R&D, Supply, Commercial) product plans encompassing all key operational deliverables associated with the PST strategy
• Develop team meeting agendas and minutes, including mechanisms to drive accountability of actions across the PST members
• Strong objective advisor to PSTL to maximize team effectiveness
• Close collaboration with R&D and Tech. Ops PM’s to ensure operational alignment of R&D and manufacturing activities to PST endorsed deliverables and priorities
• Program management support of PST-related, non-R&D, cross-functional initiatives (i.e. launch readiness purpose driven task forces)
• Operationalize and drive the annual planning processes from a PST perspective, i.e. Product Strategy, Lifecycle Management, Strategic Product Plans, Brand Plans, Budgeting, Long Range Planning
• Facilitate collection, alignment and validation of PST Sales & Marketing budget ensuring alignment to PST strategy
• Facilitate preparations and analyses of PST business reviews, goal setting and routine evaluation processes, and progress against PST strategy and action plans
• Close collaboration with PSTL and PST functional team members to ensure coordinated evaluation of product opportunities/ scenarios and development of comprehensive integrated recommendations (e.g. to Governance Committees) and strategic and operational product plans based on PST defined objectives.
• Promote visibility and transparency of information within the PST, across PST-aligned Project Teams and other forums to accelerate decision making, obtain alignment, and increase foundational knowledge, identify and communicate product and PST related objectives, issues, risks, and where applicable, facilitate cross-PST/BU discussion on impact.

10%
• Active participations in the CP&PM team and PM forums to deliver CP&PM initiatives and build a center of program and project management excellence

Proportion of above responsibilities will be re- aligned if assigned this responsibility
BU Business Partner as Incremental responsibility, as assigned
• Support for BU Leadership Team meetings as requested
• In collaboration with BU Leader,
o track BU performance vs. goals, facilitate governance reporting (e.g. In- Line Committee, ExCo updates),
o Coordinate and optimize decision making and cross-PST information flow,
o Facilitate BU Strategic Planning and budget planning processes
• Lead BU cross-PST organizational projects (either strategic and/or operational) as requested by the BU leader
• Collaborate with key functional stakeholders to develop, validate, and disseminate key BU, strategic, financial, and product related deliverables (major issues, risks, opportunities) to appropriate forums
• Collaborate in advisory capacity with other Product Strategy Program Managers, PSTL’s, BU Heads, and other key stakeholders to cultivate cross- BU/PST opportunities to maximize synergies for in-line performance (i.e. shared investments, services, innovations, etc.).

Education & Experience Requirements
• Strong business acumen
• 10+ years’ experience in pharmaceutical development and commercialization of branded prescription drug products with a minimum of 8 years direct experience across a diversity of therapeutic areas and all stages of development and commercialization (Phase 1 thru launch).
• 5+ years’ experience in program/project management in the pharmaceutical environment
• Demonstrated ability to work without routine supervision to deliver key accountabilities
• Strong knowledge and understanding of global product development and commercialization in the pharmaceutical industry.
• Significant experience in managing cross-functional, global teams; experience facilitating multi-disciplinary commercial teams strongly preferred.
• BS in scientific discipline, or MBA with relevant pharmaceutical industry experience
• Experience developing business cases


Shire's Brave culture offers employees with diverse backgrounds the opportunity to enable those with life altering conditions to lead better lives.

Exosome Diagnostics develops biofluid-based molecular diagnostic tests for use in personalized medicine. Exosomes and other microvesicles are shed into all biofluids, including blood, urine and cerebrospinal fluid, forming a highly enriched source of intact nucleic acids. Exosome Diagnostic’s proprietary technology makes use of this natural enrichment to achieve high sensitivity and specificity for detecting rare transcripts of the genes responsible for cancers and other diseases.

We are expanding our R&D facility in Cambridge MA and are looking for a Senior Scientist with assay development experience in nucleic acids, particularly in the field of biomarker discovery.This is a responsible position, requiring an individual who can work both independently and as part of a team. This opportunity will enable personal and professional development and the unique opportunity to influence and contribute in the dynamic working environment of a rapidly growing company, developing a cutting edge technology for molecular diagnostics in personalized medicine.

This position requires an individual with an entrepreneurial mindset who is adaptable and able to fill different roles and responsibilities. The ideal candidate has experience with NGS, digital PCR, and qPCR array and will be highly organized with an eye for details and good communication skills.

Key responsibilities include:

•  Developing nucleic acid based assays for biomarker screening and validation.

•  Project management and supervision of Technical Assistants.

•  Support of customer service projects.

•  Reporting and documenting results and progress to colleagues and clients.

Qualifications:

•  PhD in a relevant scientific field with 5+ years of experience from a molecular biology laboratory, preferably in industry or biotech.

Desired Skills:

•  Highly experienced in a variety of molecular biology techniques including nucleic acid extraction, amplification and detection.

•  Able to closely follow the scientific field of biomarkers in oncology.

•  Self-motivated with ability to prioritize and schedule multiple concurrent projects.

•  Have good communication skills and ability to implement technologies developed by R&D, into a CLIA environment.

•  Excellent work ethic with high energy level.

•  Prior experience working in biofluids is a plus

What we offer:

•  Competitive salary and benefits package.

•  An attractive location in the vibrant Boston/Cambridge community of biotech and academic research.

At Exosome Diagnostics, we are translating cutting edge science into real clinical products to benefit patients and doctors. We encourage the honest exchange of ideas and a culture of collaboration within the company, to help the exceptional people who work here to excel and to reach company goals.

How to apply: Interested candidates should submit a resume (Word or PDF format) to careers@exosomedx.com.

Please put [2677763] (Senior Scientist Mol Diag)  in the subject line.

Primary Duties

The Integration Lead provides advice, leadership and oversight for the development, planning and implementation of acquisition integrations aligned to the deal business strategy and designed to optimize value capture; these efforts require working crossfunctionally for the entire transaction life-cycle including: pre-deal analysis, the development of integration project plans, and post-closing implementation.

Responsibilities

80% of Time -
• Define integration Critical Success Factors (CSFs) and directly manage all planning, execution, separation, integration and cross-organizational restructuring activities related to postmerger initiatives within complex business operational environments and that are aligned to agreed CSF’s.
• Responsible for pre-deal cross-business integration assessment (issues, risks, opportunities, strategy) aligned to over-arching deal/business strategy and presentation of relevant materials to senior management (e.g., ExCo, BOD).
• Ensure clear understanding of business strategy to align work and decisions accordingly.
• Working collaboratively with Shire leaders, accountable for the creation and delivery of a disciplined crossbusiness integration strategy, process and execution plan; be able to adapt and re-calibrate plans as the situation evolves.
• Lead cross-functional integration and integration management office teams; be able to steer people effectively through the transition.
• Responsible for consolidating and reporting all integration progress to executive teams.
• Build strong ties with Sr. Management team of acquired organization and be able to pro-actively identify and problem-solve potential issues.
• Identify early (and pro-actively) the constraining factors that are unspoken and unseen; surface potential issues.
• Overall cross-business program tracking and reporting - Analyze, document and communicate program objectives and requirements across the organization and the Integration teams; facilitate activities across the functional and business teams to define project scope, identify resource requirements, articulate deliverables, develop timetables, and facilitate reporting; working with project manager, create consolidated/integrated
program milestones, interdependencies and communication plans; facilitate working sessions to define transition plans, activities and contingency plans
to eliminate obstacles; monitor progress/success versus agreed CSF’s.
• Cross-business synergy/budget tracking and reporting – collaborate with Finance and Integration team members to plan for synergy achievement and associated budget to achieve agreed synergies; confirm rollout synergy and
budget tracking tools and templates to be used; define process and timelines for ongoing tracking and reporting; working with Finance and PM, collect, refine and consolidate synergy/budget data for integration team and executive reporting.
• Integration event management – monitor readiness activities in advance of transition events to ascertain ability to move forward with event; define mitigation activities and develop contingency plans as needed to optimize for success.

20% of Time-
Responsible for ongoing refinement and delivery of the methods and tools to be used by the integration teams in support of predeal analysis and post-merger integration activities and participate in integration activities as assigned.

Education and Experience Requirements

• 10 years acquisition integration-related experience with at least 5 years in a
leadership role and demonstrated ability to assess, improve, and execute
acquisition integration strategy across strategy, finance and operations
• Direct experience with varying sizes/complexity of integrations (start up, small, mid-size companies), preferably within the pharmaceutical environment
• Strong overall senior business manager who has played a significant role in
realizing performance improvements or delivering an operational turnaround
within a short period of time
• Undergraduate degree required, MBA preferred

Shire's Brave culture offers employees with diverse backgrounds the opportunity to enable those with life altering conditions to lead better lives.

The VP of IT position has full leadership responsibility for the IT organization in a Science driven biotechnology Company. This key progressive IT leader will work collaboratively with the senior leadership team to ensure the strategic growth objectives of the business are supported by the IT organization and achieved.

Position Description

• Reporting to CFO, the VP of IT will:
• Be responsible for all aspects of IT including strategic alignment and planning, governance, architecture, information management, solution delivery and service management of a Science driven, biotechnology research and development company. Initial focus will be on strategic alignment and planning, architecture, solution delivery and service management.
• Be a key leader in supporting the longer term strategic plan for the company...one that results in improve revenue growth and profitability.
• Establish and executes on the IT plan in support of the company growth plans
• Ensure the overall IT organization is aligned to help drive desired growth results. Must ensure underlying growth processes and infrastructure are in place.
• Collaborate cross-functionally with key business stakeholders to identify, prioritize and drive improvements in Company IT capability.
• Ensure clear feedback process from customers are incorporated into IT solutions
• Attract, develop, engage and retain key talent

Required Skills

• Be able to lead development and execution of a progressive, realistic IT strategy in support of company strategic growth plans
• Be a Visionary...think beyond the current business and capability needed.
• Possess strong vendor management skills
• Engage other thought leaders and IT strategic thinkers
• Have a Customer Focus
• Have a deep understanding of key technology changes in industry as it applies to translational biology and personalized medicine
• Be a strong collaborator with scientific/business/functional leaders
• Provide inspirational leadership and have strong communication Skills
• Attract, develop, engage and retain high potential, high performing teams.
• Possess strong multi-cultural leadership skills.
• Have a financial acumen and be able to prepare/achieve a realistic annual operational and investment plan that supports business growth.
• Provide realistic cost/benefit analysis.
• Strong project planning and execution that provides and meets solid forecasts.
• Effective resource deployment to drive growth.
• Lead/drive key business processes for IT (strategy, operational planning and leadership capability).

Required Experience

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements are representative of the knowledge, skill, and/or ability required.   

• Advanced Degree in Computer Science, Biology, Chemistry, or related field and / or related / equivalent experience.
• Extensive implementation and management experience with a Science driven BioTech or Pharmaceutical,
• Experience managing, Oracle e-Business Suite ERP systems, as well as Work Day and SharePoint. Thorough understanding of the ERP functional and technical landscapes of these systems.
• Fifteen (15) + years experience managing information technology within FDA regulated companies.
• Fully knowledgeable of the systems development life cycle, structured analysis, design and programming techniques, programming languages, file access methods, web-based tools / solutions, system utilities and development tools, application software packages, and PC-based packages used in development or support of production systems.
• Experience managing IT operating budgets in excess of $2.
• Expertise in leading and managing a professional IT staff (15+).
• Broad, state-of-the-art technology awareness that can be applied creatively to business problems and opportunities.
• Experience in leading inter-organization change to increase efficiency by the implementation of technology.
• Expertise in investigating, negotiating and selecting outside services and computer software.

The Patent department at the Novartis Institutes for Biomedical Research (NIBR) is recruiting for an entry level chemistry searcher to join the Search and Analytics (S&A) team located at our research site in Cambridge, MA, USA.
You will be a member of a global team of information professionals responsible for conducting comprehensive search and analysis of scientific and patent information in support of research activities, patent preparation and prosecution as well as business development activities. Primary responsibility will be to provide search and analysis to support patentability, freedom to operate, due diligence and validity analysis to chemistry patent practitioners.

Duties and Responsibilities:
• Conduct patent search and analysis, resulting in the timely delivery of value added search reports based on in-house established protocols
• Perform comprehensive landscape, freedom to operate, novelty, validity and infringement searches in worldwide professional patent and scientific literature databases related to small molecule therapeutics
• Evaluation of the results according to scientific and patent relevant criteria
• Manage the development and timely delivery of current awareness alerts in support of active research programs based on in-house established protocols
• Maintain proficiency with commercial patent resources and other proprietary databases
• Iteratively communicate with the NIBR practitioners to insure a clear understanding of the scope of the request and draft informative reports that clarify and summarize search results
• Create and maintain a strategic partnership with key stakeholders in NIBR
• Attend internal and external meetings, conferences and courses
• Liaise with other groups with other information organizations within Novartis to insure effective knowledge sharing

*EEO Statement The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.*Minimum requirements

• Bachelor’s of Science in Chemistry or related scientific discipline
• Familiarity with the use of SciFinder, PubChem and structure drawing tools
• Understanding of the drug development and approval process
• 0-3 years of experience in the Pharma/Biotech Industry, preferably in functions related to patent and scientific information
• Interest in patents while maintaining a contemporary knowledge of science
• Strong customer-service focus to build and sustain good working partnerships with key stakeholders
• Effective analytical, presentation and communication skills
• Ability to work independently as well as collaboratively in a team
• Strong organizational and time management skills
• Flexible with excellent attention to detail
• Fluency in English (oral/written)

Compass Therapeutics is an antibody discovery and development company focused on comprehensively drugging the tumor-immune synapse with combinations of human monoclonal antibodies, multiclonals and engineered protein constructs.  Compass is industrializing antibody discovery and decentralizing biologic validation through a partnership-first mentality that leverages best-in-class technologies and top-tier academic laboratories around the world.  Novel scientific insights are validated and explored deeply inside our labs before Compass pursues the best proprietary combinations of therapeutics into human clinical trials. 

In 2015, Compass quietly closed a $120mm Series A financing to fund our ambitious plan to build a fully-integrated biopharmaceutical company from the ground up.  Our investors are among the most sophisticated venture capitalists in the industry who exemplify our philosophy of building long term economic value only by delivering therapeutics with meaningful efficacy beyond standard of care.  They include OrbiMed Advisors, Fidelity Biosciences, Borealis Ventures, Google Ventures and a handful of smaller VCs and passionate angel investors.

Our Protein Analytics Group is seeking a Scientist or Senior Scientist at our Cambridge, MA site.

Principal Responsibilities:

• Perform analytical characterization of antibodies and other biologics with a main focus on binding kinetics, in support of drug discovery and clinical development
• Closely collaborate with other discovery groups and serve as an analytical subject-matter expert to enable the design and execution of antibody functional characterization
• Act as a scientific and technical resource on a variety of protein analytical techniques
• Track literature and monitor developments in relevant fields to develop new assays and/or improve existing practices
• Cure Cancer.

Preferred Qualifications:

• Solid technical knowledge and hands-on experience using SPR (Biacore) and/or BLI (Fortebio) for affinity measurement, ranking of binders and epitope binding & mapping
• Experience with biochemical & biophysical methods for protein characterization such as SEC/RP/IEX-HPLC, SEC-MALS, Mass Spec, SDS-PAGE, DSC/DSF
• Microsoft Excel programming skills for data transfer, deposition, analysis and statistical characterization using Prism or Sigmaplot
• Excellent record keeping abilities to adequately document analytical data
• SOPs writing and mentoring junior scientists
• Ability to work in a fast-paced environment, properly manage priorities and maintain timelines for multiple projects
• Strong desire to learn new concepts and techniques

Basic Qualifications:

• Ph.D. with relevant experience

Compass Therapeutics offers individually-tailored compensation packages which include competitive cash compensation, meaningful equity participation, comprehensive healthcare and adoption benefits, continuous career development, sabbatical programs, education reimbursement and many other benefits aligned with our philosophy of putting our team first.  Our labs are located at 450 Kendall Street in Cambridge, MA.