The Broad Institute stands on the leading edge of biomedical research, with a mission to broadly disseminate discoveries and information to the scientific community and general public. The Broad research is pursued through a blend of academic and industrial-scale production of genetic, biological and chemical outputs, with scientists from Broad, MIT, Harvard and the Harvard-affiliated hospitals working side-by-side.

The Director, IP will be responsible for leading and directing the IP function of the Institute, in order to identify, secure, protect and defend the Broad intellectual assets with the purpose of adding meaningful value to the Broad mission and goals.  In this role, the Director, IP will collaborate closely with the Chief Business Officer (CBO), with input from the Early Stage IP Strategist and the Special Advisor to the Director, to inform and advise senior leadership regarding opportunities and risks in all areas of IP, including patents, trademarks, copyrights, designs, protection of research materials and information.  

Additionally, the Director, IP will partner with Institute investigators and program and platform directors to develop and implement IP strategies.  The Director, IP will also partner with internal transactions counsel and members of the business development team to address licensing and other matters related to the Institute technology commercialization efforts. Further, the Director, IP will direct the efforts of outside patent prosecution counsel and work with external litigation counsel, affiliate institutions and internal stakeholders to manage prosecution and litigation strategies related to IP.  

This position will report to the General Counsel and be a key member of the Institute Office of Strategic Alliances and Partnering (OSAP). For this role, Broad seeks an energetic, insightful patent attorney with 10+ years of relevant experience and strong business sense to join a collaborative team, with a focus on strategic oversight of a diverse and rapidly growing patent portfolio.

PRIMARY RESPONSIBILITIES:
- Generally provide lead IP legal support Work closely with senior leadership to understand the needs of the Institute and offer guidance on intellectual property matters, in addition to supporting the creation of an intellectual property strategy aligned with the Broad mission and goals
- Lead and mentor the Institute IP legal team
- Oversee and manage the Broad intellectual property portfolio
- Evaluate scientific and novel aspects of Broad inventions and patentability
- Manage patenting process for inventions generated from multi-disciplinary research and often jointly-owned by multiple Broad partner institutions, including management of process, costs/budget and attorney selection
- Work closely with CBO and OSAP leadership to identify optimal IP and commercialization strategies, with input from scientific leadership, institutional leadership as well as external advisors, as appropriate
- Maintain patent portfolios strategically and cost-effectively in the appropriate geographies, which will include identifying IP rights of high value to Broad and potential synergies across portfolios
- Effectively and regularly communicate with Broad investigators and tech transfer offices of Broad partner institutions
- Provide education to the Broad community on intellectual property matters
- Manage outside patent prosecution counsel
- Manage the Institute IP budget
- Draft and negotiate the intellectual property-related terms of the Institute complex strategic agreements
- Support alliance management and serve as a member of the JPCs for key partnerships
- Generally promote and support Broad policies, procedures, mission, values and ethics.
- JD/PhD in life sciences required.
- 10+ years of relevant experience, preferably with a combination of experience at a major law firm and in-house at a corporate legal department or an academic institution.
- Experience managing a significant and rapidly-growing patent portfolio and establishing effective and efficient processes to identify, capture and strategically manage intellectual assets.
- Direct patent prosecution experience a plus.
- Significant corporate and academic transactional and contract negotiation experience, with a focus on intellectual property and scientific collaborations.
- Demonstrated ability to analyze legal, institutional and commercial risks and propose creative solutions.
- Excellent interpersonal communication skills (written and verbal).
- Strong organizational, problem-solving and analytical skills.
- Ability to manage multiple priorities with tight deadlines.
- Versatility, flexibility and a willingness to work with constantly changing priorities.
- Team player who can work independently and thrives on a fast-paced and demanding environment.
- A passion for science and experience with early-stage biomedical technologies including therapeutics, diagnostics and research tools.Entrepreneurial, self-starter and highly independent.The Broad Institute will not offer visa sponsorship for this opportunity.

EOE / Minorities / Females / Protected Veterans / Disabilities

To apply for this position, please CLICK HERE

The Broad Institute is in search of a highly motivated and capable Research Scientist to join the biochemistry/biophysics group within the Center for the Development of Therapeutics (CDoT). CDoT is committed to developing and applying novel drug discovery approaches and technologies to address critical unmet medical needs based on human genetic insights from cardiovascular and oncological diseases. The successful candidate will share this commitment and be part of a multidisciplinary team that drives innovation and execution to solve therapeutic challenges.

Characteristic Duties:    
- Recombinant protein design, cloning, expression, and purification using standard and novel techniques
- Protein characterization using biochemical and biophysical assays
- Developing new approaches to isolate challenging proteins
- Evaluating/applying technologies in novel ways to support discovery efforts
- Presenting results in cross-functional project teams

Minimum Requirements:    
Ph.D. in Structural Biology, Biochemistry, Biophysics, or related life science field. Significant experience in recombinant protein science from different cellular systems (e.g. bacterial, insect, and mammalian). Experience in insect cell systems a plus. Significant experience in standard purification techniques (e.g. affinity, ion exchange, size-exclusion chromatography)

Experience with techniques such to functionally characterize proteins (e.g. surface plasmon resonance, multi-angle light scattering, ITC, DSC, and mass spectrometry Broad experience with a variety of biochemical methods for protein characterization (quantitation, chemical modification strategies, cross linking, limited proteolysis). Familiarity with purifying protein constructs for crystallization and obtaining crystals a plus. A proven record of successful interactions within multidisciplinary teams.

The successful candidate will be a results-focused, team-oriented, creative, bench scientist, able to excel in a fast-track environment. He or she must be self-motivated, detail-oriented and exhibit strong problem solving skills. In addition, the successful candidate should be a clear and effective communicator, demonstrating strong interpersonal skills to enable collaboration with project teams, peers, and management in identifying and achieving research goals.The Broad Institute will not offer visa sponsorship for this opportunity.

EOE / Minorities / Females / Protected Veterans / Disabilities

To apply for this position, please CLICK HERE

Jounce Therapeutics is focused on the discovery and development of first-in-class cancer immunotherapies designed to work not by treating a patient's tumor directly, but instead by harnessing the patient's immune system to seek out and attack cancerous cells and tumors.

Job Description:

The successful candidate will be an integral part of a team of scientists engaged in the discovery and evaluation of novel cancer immunotherapeutic candidates. Primary responsibilities will be conducting translationally focused studies to support drug programs through understanding target expression in tumor indications and immune cell subsets. Candidate will be working with human samples and ideal candidate will have significant experience in handling human samples and in flow cytometry as well as molecular techniques to include: RNA handling, quantitative PCR, and reporter gene assays. S/he will be responsible for data analysis, thorough documentation of the work, and clear communication of results in group settings. The successful candidate will function well within and across teams in a collaborative environment.

Qualifications:

•             Bachelors or Master’s degree in Immunology or a related field with 2-5 years relevant laboratory                 experience. Strong preference given to candidates with industry experience.

•             Significant hands-on experience with flow cytometry including multi-parametric flow and            immune cell sorting, with preference given to candidates experienced in isolation and            manipulation of human blood and blood components.

•             Flow cytometry analysis and experience with FlowJo software desired.

•             Experience in RNA handling, extraction and quantitative (TaqMan) PCR is essential.

•             Preference given to candidates with experience working with primary human tumor tissue samples and 3D co-culture systems from primary tumors

•             Excellent organizational skills and oral and written communication skills.

•             Capable of contributing independently and able to thrive in a highly collaborative, fast-paced,    team-oriented environment with colleagues from diverse disciplines.

To be considered for this role, please submit your resume to Careers@Jouncetx.com with the job title in the subject line of your email.

We are an equal opportunity employer offering a competitive salary and benefits package.

All applicants should be legally entitled to work for any employer in the US.

Note to Employment Agencies: Please do not forward any agency resumes. The company will not be responsible for any fees related to resumes that are unsolicited.

Summary : The Pharmacovigilance Risk Management Lead is responsible for Risk Management and Pharmacovigilance Plans and risk managementactivities for Client products, including the management of the operations of benefit risk committee and resulting action plansThis includes Development and management Risk Management and Pharmacovigilance Plans and risk management activities for Client products,including the management of the operations of benefit risk committee and resulting action plans

Accountabilities :·

• Summarize safety data from investigational and marketed use
• Authoring RMP’s, REMS to meet regulatory and internal deadlines
• Critically review documents produced for scientific content and alignment with company position, clarity, accuracy, and consistency and ffacilitate document review by other contributors·
• Ensure all safety regulatory documents are processed and submitted according to regulatory requirements·
• Manage portfolio of products/projects related to risk management·
• Write and prepare risk management documents, including Risk Management Plans, Pharmacovigilance Plans and Risk Minimization Plansor REMS for submission to regulatory agencies·
• Ensure all risk management documents are prepared according to regulatory requirements and facilitate review and sign-off·
• Assist in the management of Risk Management project timelines
• Represent Risk Management on cross functional teams·
• Interface with other Client functional groups such as Regulatory Affairs, Clinical Development, Medical Affairs, Quality, business units,as needed·
• Contribute to on-going process enhancement for safety surveillance such as developing standard procedures and templates·
• Participate in other teams and committees as assigned

Minimum Qualifications:

• MD, PHD, or Pharm D with specialty training in functional area at least 4 plus years of experience in pharmaceutical industry within Drug safety/Pharmacovigilance with both investigational and marketed products·
• At least 3 years of experience writing and preparing risk management documents, including Risk Management Plans,Pharmacovigilance Plans and Risk Minimization Plans or REMS for submission to regulatory agencies.

Preferred Experience: ·

• Previous experience in bioscience preferred·
• Product defense before a national or international regulatory authority a plus·
• Ability to read and analyze scientific and medical literature·
• Ability to work with interdisciplinary, highly matrixed teamEqual Employment Opportunity

Summary : The Pharmacovigilance Risk Management Lead is responsible for Risk Management and Pharmacovigilance Plans and risk managementactivities for Client products, including the management of the operations of benefit risk committee and resulting action plansThis includes Development and management Risk Management and Pharmacovigilance Plans and risk management activities for Client products,including the management of the operations of benefit risk committee and resulting action plans

Accountabilities :·

• Summarize safety data from investigational and marketed use
• Authoring RMP’s, REMS to meet regulatory and internal deadlines
• Critically review documents produced for scientific content and alignment with company position, clarity, accuracy, and consistency and ffacilitate document review by other contributors·
• Ensure all safety regulatory documents are processed and submitted according to regulatory requirements·
• Manage portfolio of products/projects related to risk management·
• Write and prepare risk management documents, including Risk Management Plans, Pharmacovigilance Plans and Risk Minimization Plansor REMS for submission to regulatory agencies·
• Ensure all risk management documents are prepared according to regulatory requirements and facilitate review and sign-off·
• Assist in the management of Risk Management project timelines
• Represent Risk Management on cross functional teams·
• Interface with other Client functional groups such as Regulatory Affairs, Clinical Development, Medical Affairs, Quality, business units,as needed·
• Contribute to on-going process enhancement for safety surveillance such as developing standard procedures and templates·
• Participate in other teams and committees as assigned

Minimum Qualifications:

• MD, PHD, or Pharm D with specialty training in functional area at least 4 plus years of experience in pharmaceutical industry within Drug safety/Pharmacovigilance with both investigational and marketed products·
• At least 3 years of experience writing and preparing risk management documents, including Risk Management Plans,Pharmacovigilance Plans and Risk Minimization Plans or REMS for submission to regulatory agencies.

Preferred Experience: ·

• Previous experience in bioscience preferred·
• Product defense before a national or international regulatory authority a plus·
• Ability to read and analyze scientific and medical literature·
• Ability to work with interdisciplinary, highly matrixed teamEqual Employment Opportunity

SUMMARY

• This role is responsible for aggregate review and reporting of safety data from various sources in support of regulatory aggregate reporting requirements, as well as safety surveillance and risk management activities pertaining to Client products.
• Candidates must have authored Safety/Regulatory documents such as PBRER’s, DSUR’S, PRAC Response, Regulatory submission, RMP Plans, Company Core Safety Documents & SCS
• In addition Candidates must have experience in managing and conducting signal detection for Pharmaceutical products.

ACCOUNTABILITIES

• Creation, coordination, preparation, and completion of aggregate safety reports for Client products (e.g.PSUR, PBRER, PADER) for submission to regulatory agencies around the world, as well as internal safety surveillance documents/’white papers’
• Handling internal ad hoc queries/reports, analyzing/summarizing safety data from various sources, and management of signal detection activities
• Development and management Risk Management and Pharmacovigilance Plans and risk management activities for Client products, including the management of the operations of benefit risk committee and resulting action plans
• Summarize safety data from investigational and marketed use
• Author high quality aggregate safety reports including PSUR, PBER, PADER, EU RMP, REMS to meet regulatory and internal deadlines.
• Critically review documents produced for scientific content and alignment with company position, clarity, accuracy, and consistency and facilitate document review by other contributors
• Ensure all safety regulatory documents are processed and submitted according to regulatory requirements
• MUST have authored Safety/Regulatory documents such as PBRER’s, DSUR’S, PRAC Response, Regulatory submission, RMP Plans, Company Core Safety Documents & SCS
• In addition MUST have experience in managing and conducting signal detection for Pharmaceutical products.
• Participate in ongoing safety data review and analysis for products in designated therapeutic areas
• Manage portfolio of products/projects related to risk management
• Write and prepare risk management documents, including Risk Management Plans, Pharmacovigilance Plans and Risk Minimization Plans or REMS for submission to regulatory agencies
• Ensure all risk management documents are prepared according to regulatory requirements and facilitate review and sign-off
• Assist in the management of Risk Management project timelines
• Represent Risk Management on cross functional teams
• Interface with other Client functional groups such as Regulatory Affairs, Clinical Development, Medical Affairs, Quality, business units, as needed

QUALIFICATIONS

• Bachelor’s degree in a biologic/medical/clinical/nursing field; advance degree desired
• Knowledge of US and Ex-US pharmacovigilance risk management regulations
• Excellent analytical and problem solving skills
• Excellent communication and interpersonal skills
• Excellent scientific writing skills
• Scientific/clinical knowledge
• Must have authored Safety/Regulatory documents such as PBRER’s, DSUR’S, PRAC Response, Regulatory submission, RMP Plans, Company Core Safety Documents & SCS
• In addition must have experience in managing and conducting signal detection for Pharmaceutical products.

SUMMARY

• This role is responsible for aggregate review and reporting of safety data from various sources in support of regulatory aggregate reporting requirements, as well as safety surveillance and risk management activities pertaining to Client products.
• Candidates must have authored Safety/Regulatory documents such as PBRER’s, DSUR’S, PRAC Response, Regulatory submission, RMP Plans, Company Core Safety Documents & SCS
• In addition Candidates must have experience in managing and conducting signal detection for Pharmaceutical products.

ACCOUNTABILITIES

• Creation, coordination, preparation, and completion of aggregate safety reports for Client products (e.g.PSUR, PBRER, PADER) for submission to regulatory agencies around the world, as well as internal safety surveillance documents/’white papers’
• Handling internal ad hoc queries/reports, analyzing/summarizing safety data from various sources, and management of signal detection activities
• Development and management Risk Management and Pharmacovigilance Plans and risk management activities for Client products, including the management of the operations of benefit risk committee and resulting action plans
• Summarize safety data from investigational and marketed use
• Author high quality aggregate safety reports including PSUR, PBER, PADER, EU RMP, REMS to meet regulatory and internal deadlines.
• Critically review documents produced for scientific content and alignment with company position, clarity, accuracy, and consistency and facilitate document review by other contributors
• Ensure all safety regulatory documents are processed and submitted according to regulatory requirements
• MUST have authored Safety/Regulatory documents such as PBRER’s, DSUR’S, PRAC Response, Regulatory submission, RMP Plans, Company Core Safety Documents & SCS
• In addition MUST have experience in managing and conducting signal detection for Pharmaceutical products.
• Participate in ongoing safety data review and analysis for products in designated therapeutic areas
• Manage portfolio of products/projects related to risk management
• Write and prepare risk management documents, including Risk Management Plans, Pharmacovigilance Plans and Risk Minimization Plans or REMS for submission to regulatory agencies
• Ensure all risk management documents are prepared according to regulatory requirements and facilitate review and sign-off
• Assist in the management of Risk Management project timelines
• Represent Risk Management on cross functional teams
• Interface with other Client functional groups such as Regulatory Affairs, Clinical Development, Medical Affairs, Quality, business units, as needed

QUALIFICATIONS

• Bachelor’s degree in a biologic/medical/clinical/nursing field; advance degree desired
• Knowledge of US and Ex-US pharmacovigilance risk management regulations
• Excellent analytical and problem solving skills
• Excellent communication and interpersonal skills
• Excellent scientific writing skills
• Scientific/clinical knowledge
• Must have authored Safety/Regulatory documents such as PBRER’s, DSUR’S, PRAC Response, Regulatory submission, RMP Plans, Company Core Safety Documents & SCS
• In addition must have experience in managing and conducting signal detection for Pharmaceutical products.

Description

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.

Position Title: Scientist I/II, Analytical Development

Department: Analytical Development

At Pulmatrix, we are developing innovative inhaled therapies to address serious pulmonary disease using our clinically validated, proprietary iSPERSE technology. Leveraging the unique capabilities of iSPERSE to dramatically advance inhalation technology, we can create new therapies to improve patient outcomes.

Our pipeline of inhaled therapies represents innovative, first-in-class products. Our proprietary pipeline of novel, therapies for rare, orphan diseases is led by PUR1900, an inhaled anti-infective to treat fungal infections in cystic fibrosis or immune compromised patients. Our pipeline in major pulmonary diseases developed in collaboration with partners is led by PUR0200, a branded generic in clinical development for chronic obstructive pulmonary disease (COPD).

iSPERSE is a, dry powder technology developed, patented and validated by Pulmatrix scientists and engineers to improve how drugs are directed into the lungs. iSPERSE products are designed to maximize local drug concentrations and reduce systemic side effects, in order to make possible a new generation of inhaled therapies to improve patient outcomes.

Overall Responsibility:

We are seeking a highly motivated, experienced Scientist to join the Analytical Development group to provide technical leadership and hands-on performance in support of Pulmatrix development programs. This role will be responsible for defining testing strategies, developing analytic methods and providing analytic technical support within and external to Pulmatrix. The ideal candidate will have expertise in chromatographic method development and the experience troubleshooting analytic problems.  The position will be responsible for providing the key analytic support to multiple internal and external development programs.

The work environment is highly collaborative, requires excellent communication skills and the ability to be part of a cross-functional product development team. The successful candidate must have previous analytical development experience in support of pharmaceutical product development. The candidate is expected to support to our CMC strategy for novel pulmonary formulations through participation on CMC project teams and have a proven ability to meet development goals within aggressive timelines.

Technical Skills:

–       Command of chemistry and analytical chemistry principles

–       Experience in the applied use of different chromatographic techniques (HPLC/UPLC/GC), LC/MS as well as UV-Vis, KF Moisture analysis and associated hardware and computer interfaces with an emphasis on small molecule analysis

–       Proficient in the use of wet chemistry techniques and general analytical laboratory equipment

–       Experience in the development and execution of methods focused on aerosol characterization or characterization of inhaled drug products is a strong plus

–       Ability to independently plan, execute and document analytic method development, analytic analysis and assessment activities

–       Experienced with the Waters HPLC systems and Empower strongly desired

–       Strong qualitative and quantitative data analysis and interpretation skills following good analytical laboratory practices and an understanding of cGMP/cGDP

–       Knowledge of ICH analytical method guidelines is required

Personal Skills:

–       Strong oral and written communication skills, with the ability to prepare and present data to internal and external working teams

–       Excellent data recording, interpretation and management including a strong attention to detail

–       Reliable, self-motivated individual with positive attitude

–       Team-oriented with ability to work with junior and senior Analytical development staff including the review of data analysis, calculations and written reports

–       Ability to effectively manage time and prioritize tasks to meet tight timelines and shifting priorities in a fast-paced environment

–       Desire for continued training and growth opportunities, including willingness to learn new skills and contribute outside of specific area of expertise

Qualifications:

Minimum of a scientific Bachelor’s degree (Chemistry, Analytic Chemistry, Biochemistry or related field) and 8+ years of relevant industry experience in biotech/pharmaceutical R&D OR a M.Sc. with 5+ years of experience. A combination of experience and/or education will be taken into consideration for position and title.

–       May require travel

–       Must be authorized to work in the United States for any employer without the need for sponsorship

Contact: jobs@pulmatrix.com with cover letter and CV while referencing this job requisition

Repligen is a leading Bioprocess company with market leading products focused on serving the upstream, downstream, and analytical market segments in the biopharmaceutical manufacturing industry.  Our products are used in the manufacture of more than 40 approved biologics and hundreds more in development.  We are growing rapidly and are profitable. Our Products We are the market leader in the manufacture of Protein A ligands and over the last four years we have expanded our product portfolio with the addition of cell culture growth factors, disposable chromatography columns, and stainless steel filtration systems (including associated controllers and consumables).

Repligen is an innovative life science company focused on the development, production and commercialization of high-value consumable products used in the process of manufacturing biological drugs. We are seeking an upstream Bioprocess Engineer to conduct application study, scale-up/down and single-use product development with Repligen’s ATF perfusion technology and recombinant media supplements for biologics protein production. This position resides within the Research and Development group and will report to the Senior Director, Upstream Bioprocess Development.

Responsibilities: 

• Perform lab scale fedbatch and perfusion bioreactor operation and engineering scale-up/down to demonstrate performance of ATF system and growth factors in industrial CHO cell culture applications

• Participate in single-use product development, conduct product mechanical testing, characterization and qualification studies, and work with materials vendors/suppliers on materials sourcing and screening

• Perform study design and data analysis, write summary report and present findings

• Provide customer technical support and troubleshooting

• Work on joint technology projects with Manufacturing and with partner companies and customers

Qualifications:   

• BS/MS in biochemical engineering, biomedical engineering, or other related fields with solid understanding of engineering principles

• 2-4 years’ experience in cell culture/fermentation process development (media design & optimization, fedbatch and perfusion bioreactor process optimization, scale-up/down, etc.) or bioprocessing product development (mechanical testing, characterization and application study) in the biotechnology/pharmaceutical industry

• Experience in single-use product development (mechanical testing, characterization, applications study, extractables/leachable studies, and gamma irradiation study) is required

• Familiarity with media design, fed-batch or perfusion bioreactor operation, controller configuration/automation, and cell retention device (ATF or TFF) setup & optimization are highly desirable

• Detail oriented with excellent prioritization and organizational skills

• Superior analytical and problem solving skills

• Excellent oral and written communication skills

• The ability to work independently and in a team setting, as well as flexibility to work off-hours and weekends (on as needed basis) are also required. Familiarity with quality system for documentation a plus

Our Company

Repligen is a leading Bioprocess company with market leading products focused on serving the upstream, downstream, and analytical market segments in the biopharmaceutical manufacturing industry.  Our products are used in the manufacture of more than 40 approved biologics and hundreds more in development.  We are growing rapidly and are profitable.

Our Products

We are the market leader in the manufacture of Protein A ligands and over the last four years we have expanded our product portfolio with the addition of cell culture growth factors, disposable chromatography columns, and stainless steel filtration systems (including associated controllers and consumables).  

Job Description: 

The QC Analyst will report directly to the QC Manager and will be primarily responsible for performing incoming measuring and inspection of ATF systems and OPUS components, in-process testing of Repligen Bioprocessing ligands, and release of OPUS pre-packed chromatography columns.  The analytical activities supporting this position include FTIR analysis as well as HETP, and pressure vs. flow analysis of pre-packed OPUS columns. The successful candidate will support activities for facilities including collection of Environmental Monitoring data in the clean rooms as well as RODI collection and analysis.  The candidate will actively follow Repligen ISO 9001 Quality Management System in support of the Bioprocessing manufacturing processes and final product testing, including additional laboratory compliance as assigned by the QC Manager.

Responsibilities: 

• Performs final testing of finished OPUS® pre-packed chromatography columns and documents results for product release, and assists with any additional OPUS related QC requirements

• Performs in-process concentration analysis by UV

• Performs sample preparation for FTIR analysis in support of the OPUS manufacturing

• Conducts inspection, preparation, and release of incoming precisely machined plastic components for OPUS® pre-packed chromatography columns and suATF

• Carries out monitoring of controlled environments and records data for trend analysis

• May assist with OOS investigations, failure investigations and change controls associated with QC testing

Qualifications: 

• Requires college level education in Biology or related field and 4-8 years’ experience in Quality Control laboratory or equivalent

• Ability to work independently once training has been completed

• High attention to detail applied to all aspects of daily activities

• Ability to work efficiently in an ISO-9001 quality system with appropriate attention to detail in the performance of controlled procedures

• Good understanding of the fundamentals of column chromatography

• Experience using calipers and FARO for parts measuring a plus

• Experience with Agilent ChemStation and AKTA chromatography systems a plus

• Experience or knowledge of FTIR a plus

• Familiarity with microbiology techniques such as aseptic handling of materials and working within a BioSafety Cabinet

Our Company

Repligen is a leading Bioprocess company with market leading products focused on serving the upstream, downstream, and analytical market segments in the biopharmaceutical manufacturing industry.  Our products are used in the manufacture of more than 40 approved biologics and hundreds more in development.  We are growing rapidly and are profitable.

Our Products

We are the market leader in the manufacture of Protein A ligands and over the last four years we have expanded our product portfolio with the addition of cell culture growth factors, disposable chromatography columns, and stainless steel filtration systems (including associated controllers and consumables). 

The successful candidate will be responsible for QA oversight of the OPUS product line, including OPUS batch record review, report writing, review and revision to SOPs and OPUS engineering drawings and oversight of a direct report employee. The position will require management of the CAPA program pertaining to the OPUS product line, inclusive of issuing CAPAs for nonconformities identified during the audits, as well as other internal sources, such as deviations, customer audit findings and customer complaints. The successful candidate will be able to drive CAPAs to closure in partnership with the responsible departmental manager according to predetermined timelines, assisting with corrective action implementation when able.

The position will encompass performing QA review of OPUS production and QC documentation, and support activities, such as raw material release and maintaining files

Responsibilities:  • Management of OPUS product line CAPA program. Facilitate CAPA closure across the organization and assist with completing corrective actions required

• Perform Internal Audits, including scheduling, conducting and reporting audit findings, CAPA generation and management

• Assist with maintenance of the Supplier Management Program for OPUS product line and assist with conducting audits at vendor sites, when needed

• Review OPUS batch records including monthly RO/DI and weekly Environmental Monitoring, when required

• Perform QA review and approval of document change requests (DCRs) for revisions to OPUS production documents, OPUS engineering drawings and pertinent SOPs

• Facilitate the writing and closure of failure investigations and deviation reports associated with batch record review

• Perform raw material release for both Quality Control and Manufacturing materials, including raw material specification updates

• Responsible for mentoring and overseeing a direct report employee

Qualifications:   

• Bachelor’s degree in Engineering strongly preferred. Biology, Chemistry, or equivalent will be considered

• Minimum of 5 years’ experience in Quality Assurance in an ISO 9001 certified Quality Management System or equivalent

• Must have attention to detail and strong organizational skills

• Must have experience with report writing, SOP revision and following up on corrective actions with demonstrated success

• Supervisory experience, or previous experience managing direct reports

• Previous auditing experience is a plus

• Some travel may be required, up to 10% travel

Our Company

Repligen is a leading Bioprocess company with market leading products focused on serving the upstream, downstream, and analytical market segments in the biopharmaceutical manufacturing industry.  Our products are used in the manufacture of more than 40 approved biologics and hundreds more in development.  We are growing rapidly and are profitable.

Our Products

We are the market leader in the manufacture of Protein A ligands and over the last four years we have expanded our product portfolio with the addition of cell culture growth factors, disposable chromatography columns, and stainless steel filtration systems (including associated controllers and consumables).  

The successful candidate will be responsible for establishment, routine maintenance, qualification and overall management of the electronic drawing system, EDPM (The Vault). This system is used for revision control for engineering drawings as well as the repository for effective drawings in support of the OPUS and ATF Systems product lines.

The successful candidate will also be responsible for the operation, maintenance, and qualification of the Electronic Document Management System (EDMS) Syncade. This includes responsibility for the management of change requests, print packages, and issuance of controlled documents to the production and QC departments, when necessary. The position will require oversight of the Training and Development Module development, implementation and day to day operation for the Bioprocessing Operations team.

The position will also be responsible for the on-going strategy for documentation development relating to the integration of new technology / products and new product development in support of new document and batch record generation to meet ISO 9001 requirements for controlled documents.  This position will also be responsible for mentoring and overseeing a direct report.

Responsibilities: 

• Organization, operation and maintenance of the eDrawing system, EPDM

• Operation and maintenance of the eDMS Syncade

• Development, implementation, operation and maintenance of the Training and Development Module, Syncade T&D

• Maintain routine document control activities of document revision, batch record generation and label generation in support of the ATF production schedule

• Mentor and oversee Document Control Specialist direct report

• Provide audit support during customer audits o Responsible for completing relevant corrective actions to address audit observations

• Point of contact for IT with regard to necessary upgrades or changes in the EDMS software or server requirements o Write and execute validations/qualifications to support required changes

• Assist with new product documentation requirements to meet ISO 9001 requirements for controlled documentation

• Provide coverage for raw material release when required

Qualifications:   

• Requires college level education in Science or Engineering related field

  • Minimum 4+ years’ experience using electronic document and/or drawing management software

• Minimum 3 years’ experience in Syncade or Master Control EDMS software

• Experience with IO/PQ software drafting and execution

• 2-5 years of experience in an ISO 9001 environment preferred, or GMP environment in a document control role

If you are looking for a fun, interesting job where you can put your technical skills and media expertise to the test, then this is the job for you! Our client is a global biotechnology company that is dedicated to improving the lives of people with serious diseases, and they are looking for a meticulous and motivated individual to provide media solutions required by various research and development groups.  You will also have the opportunity assist with the maintenance / operation of lab equipment as well as  maintain inventory for the labs.  
Requirements for this position are:

• High School diploma or Associates Degree
• 3-5 years lab work experience

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™

Role: CRA

CLIENT: SPONSOR

Job Overview: 
The Site Relationship Manager (SRM) within Value Based Medicine (VBM) will be responsible for the overall US site management, training and quality oversight of assigned studies. These studies will explore new technologies to generate, collect and present patient data seamlessly within the clinical practice setting. The goal of the studies is to explore innovative ways to learn from clinical practice and generate insights that can be used to inform decision making at the point of care. The SRM will execute site management and provide oversight of site training and quality in accordance with Biogen SOPs/processes. This position will also take on additional project management responsibilities as delegated by the Clinical Operations Lead. This position will report into the Project’s Director within VBM. It is strongly preferred that the SRM will be based within the Cambridge area to commute to the Biogen Cambridge office on a regular basis. This role requires an individual with demonstrable clinical operations experience and proven expertise in customer service. 

Main Accountabilities: 
• Conducts Site Visits to orient and train site personnel regarding the protocol, study activities and applicable regulatory requirements. 
• Assures ongoing site compliance with the protocols, informed consent process and documentation, as well as applicable FDA regulations and/or ICH GCP Guidelines and other local regulations Critically reviews and analyzes site activities and study conduct through on-site and remote assessments/contacts. 
• Ensures timely submission of high quality of data from study sites and appropriate query resolution 
• Ensures safety and protection of study subjects according to the monitoring plan, and applicable Biogen SOPs, and ICH GCP Guidelines and/or FDA/local regulations. 
• Proactively works with sites to resolve issues, answer questions, and manage requests for study supplies. 
• Interacts and builds professional and collaborative relationships with all study personnel and Biogen personnel in order to facilitate meeting study objectives. 
• Takes on aspects of the project management as delegated by the sponsor, including development of study reports and trackers, quality metrics and risks and mitigations. 
• Responsible for development of study monitoring and management documentation and tools as delegated by the sponsor, including: Clinical Monitoring Plan, SIV slides, Regulatory Binder, Study Reference Guide, site tools, etc. 
•
• Anticipates and proactively solves study site problems/issues as they occur. Initiates, recommends and communicates corrective actions as needed. 
• Proactively communicates and escalates with all internal and external stakeholders issues identified at study sites while developing the corresponding mitigation strategies and recommended approach. 
• Prepares and submits written reports, both monitoring and administrative, in a timely, accurate, concise and objective manner. 
• Obtain, review for appropriateness, and process regulatory and administrative documents from investigator sites including site specific ICFs and essential documents. 
• Uses multiple technologies to foster, maintain, and enhance open communication 
• Train, mentor and maintain oversight responsibilities of additional Site Relationship Manager(s) assigned to the studies. 
• Communicates and provides oversight of specified vendors for quality and compliance. Performs on-site visits with specified vendors as applicable. 

Qualifications:
• Minimum of 7+ years of clinical research experience with minimum of 5+ years of CRO/sponsor monitoring. 
• Flexibility in travel to sites as needed. Expected to be on average 50% of time based on project needs. 
• Strong customer service and relationship building skills with sites (on site and remote) 
• Strong Site Management and Project Management skills including risk assessment and contingency planning 
• Demonstrate a high degree of learning agility 
• Possess a combination of critical thinking and operational know-how and efficiency 
• Demonstrated success in working independently 
• Strong communication and leadership skills 
• Strong preference for candidate local to the Biogen Cambridge office to work on campus routinely 
• Strong preference for experience with late phase and observational clinical research 
• CNS and MS experience preferred 

Education: Minimum of a Bachelor of Science degree in a health related field with clinical research experience

Summary:

The Manager/Sr. Manager, Clinical Supply Chain will manage day to day clinical supply activities and logistics within the Technical Operations Group as further described below. The Technical Operations (Tech Ops) Group is responsible for managing all aspects of AMAG Pharmaceutical’s product development and clinical/commercial manufacturing and supply.

Essential Duties and Responsibilities include, but are not limited to: 

• Responsible for implementation of clinical supply chain plans, based on clinical study protocol and clinical development plans
• Collaborate with Clinical Operations, clinical packaging sites, CROs, and others as applicable to manage all clinical supply-related activities across projects / products
• Develop, manage, and utilize appropriate inventory tracking/reporting tool(s) and metrics for maintaining clinical supply inventory
• Manage logistical shipments between sites
• Develop and maintain information and reporting, in collaboration with QA/QC/RA, to ensure and manage product expiry
• Collaborate with Clinical Operations, labeling/packaging CROs, QA and regulatory agencies to develop regulatory compliant label design and printing for finished product
• Assess, manage, and track the purchase, distribution and labeling of comparator products and other miscellaneous ancillary clinical trial material
• Collaborate with QA on vendor qualification, quality agreement, labeling/packaging, controls, and training
• Obtain demand forecast supply needs for clinical trial materials
• Develop or revise Clinical Supply related SOPs/Policies/Plans
• Other activities as assigned by department management

Desired Qualities

Ability to prioritize to meet tight deadlines and adjust to workload fluctuations. Excellent written and verbal communication skills, with a high level of attention to detail. Strong organizational, analytical and problem-solving skills, with the ability to coordinate multiple large and diverse projects simultaneously. Ability to form strong working relationships across departments while maintaining firm adherence to proper quality standards. Flexibility and willingness to work on a broad variety of techno-regulatory matters.

 Demonstrated proficiency in the following competencies: Analytical thinking, critical information seeking, strategic influencing, and results orientation

Required Experience

Education/Training/Experience

5-10 years of relevant experience in a regulated cGMP biotech/biopharma/pharma company. Relevant experience shall include – but is not limited to:

• BS/MS in science, nursing, or related discipline
• Current Good Clinical Practices (cGCPs)
• Current Good Manufacturing Practices (cGMPs)
• Experience with IXR programming/implementation required
• Experience with global clinical supply in EU and South America required
• ERP/MRP experience preferred (agnostic of which; SAP, JDE, Oracle, etc.)
• Strong understanding of product life cycle from clinical supply chain through product commercialization and life cycle management

Willingness to travel to various meetings or vendor sites, including overnight trips. Some international travel may be required.

Summary:

The Manager/Sr. Manager, Clinical Supply Chain will manage day to day clinical supply activities and logistics within the Technical Operations Group as further described below. The Technical Operations (Tech Ops) Group is responsible for managing all aspects of AMAG Pharmaceutical’s product development and clinical/commercial manufacturing and supply.

Essential Duties and Responsibilities include, but are not limited to: 

• Responsible for implementation of clinical supply chain plans, based on clinical study protocol and clinical development plans
• Collaborate with Clinical Operations, clinical packaging sites, CROs, and others as applicable to manage all clinical supply-related activities across projects / products
• Develop, manage, and utilize appropriate inventory tracking/reporting tool(s) and metrics for maintaining clinical supply inventory
• Manage logistical shipments between sites
• Develop and maintain information and reporting, in collaboration with QA/QC/RA, to ensure and manage product expiry
• Collaborate with Clinical Operations, labeling/packaging CROs, QA and regulatory agencies to develop regulatory compliant label design and printing for finished product
• Assess, manage, and track the purchase, distribution and labeling of comparator products and other miscellaneous ancillary clinical trial material
• Collaborate with QA on vendor qualification, quality agreement, labeling/packaging, controls, and training
• Obtain demand forecast supply needs for clinical trial materials
• Develop or revise Clinical Supply related SOPs/Policies/Plans
• Other activities as assigned by department management

Desired Qualities

Ability to prioritize to meet tight deadlines and adjust to workload fluctuations. Excellent written and verbal communication skills, with a high level of attention to detail. Strong organizational, analytical and problem-solving skills, with the ability to coordinate multiple large and diverse projects simultaneously. Ability to form strong working relationships across departments while maintaining firm adherence to proper quality standards. Flexibility and willingness to work on a broad variety of techno-regulatory matters.

 Demonstrated proficiency in the following competencies: Analytical thinking, critical information seeking, strategic influencing, and results orientation

Required Experience

Education/Training/Experience

5-10 years of relevant experience in a regulated cGMP biotech/biopharma/pharma company. Relevant experience shall include – but is not limited to:

• BS/MS in science, nursing, or related discipline
• Current Good Clinical Practices (cGCPs)
• Current Good Manufacturing Practices (cGMPs)
• Experience with IXR programming/implementation required
• Experience with global clinical supply in EU and South America required
• ERP/MRP experience preferred (agnostic of which; SAP, JDE, Oracle, etc.)
• Strong understanding of product life cycle from clinical supply chain through product commercialization and life cycle management

Willingness to travel to various meetings or vendor sites, including overnight trips. Some international travel may be required.

Summary:

This position will report to the Vice President, Sales. The Senior Manager, Sales Training will be responsible for all aspects of training related our current marketed products (Feraheme & MuGard) along with any other future products. The incumbent will plan, develop, and facilitate all areas and phases of sales representative training, serve as facilitator of training in support of on-going field needs, managers’ meetings, POA meetings, National Sales Meetings and product launches while working collaboratively with sales, marketing, legal, regulatory, medical and operations.

Essential Duties and Responsibilities include but not limited to the following.

• Design and facilitation of sales training programs for customer facing sales teams (Sales, MMR) as well as training for other appropriate functional teams.
• Coordinate new hire training programs with Specialty Account Representatives, Regional Sales Directors and Medical Science Liaisons.
• Lead training sessions on CKD, selling skills, clinical study review, clinical case studies, competitive overview, account management.
• Responsible for writing article review and key selling points for disease knowledge development in the field.
• Regular “in field” experience with representatives and managers.
• Develop programs and gap assessment tools for use at regional meetings to aid in continued development of the Specialty Account Representatives skill and knowledge base.
• Incorporate all appropriate regulatory and legal compliance programs into the appropriate training programs.
• Aide in cross-functional training to other AMAG personnel, such as marketing, clinical and Managed Markets.
• Manage, design and deliver sales training content for required sales meetings.
• Work closely with marketing to develop sales force strategies to ensure product success in the marketplace.
• Based on needs assessment build all content for management training for all managers in the Hem/Onc Division.
• Maintain an up to date ISTC agenda along with Phase II classes to help develop SARs with less then two years at AMAG.
• Develop Advanced Training Class for the top 10% of the AMAG sales force.

Education/Qualification/Requirements:

This position requires a BA/BS with experience in a field or corporate sales training role.    The ideal candidate should have a minimum of 5-7 years biopharma or related industry experience. HemOnc, injectable/infusible experience preferred. Prior front-line (DM) sales management experience preferred.

Company Overview

Dimension Therapeutics is a gene therapy company focused on developing novel treatments for rare diseases.  We are focused on advancing our platform of gene therapy programs in rare diseases through clinical development, starting with lead programs in hemophilia, and building out a world-class product engine for adeno-associated virus (AAV) therapeutics.

We are looking for exceptional individuals who share our passion for developing novel therapies to treat rare diseases and advancing the field of gene therapy.

Position Summary

Oversee lab start-up and operations at Dimension’s 15,000 square foot pilot plant conducting large-scale research and process development to support our gene therapy programs.  Conduct upstream and downstream process development operations and participate in tech transfer activities.

Responsibilities

• Partner with Process Development lead scientists to ensure continuity of upstream and downstream process development
• Apply scientific concepts to the scale-up and scale-down of mammalian cell culture processes
• Conduct process improvements at near scale in SUBs (50-250L)
• Lead tech transfer of developed process and materials to external CMO partners
• Generate, manage and maintain critical data and prepare scientific reports and SOPs
• Responsible for leading the generation of process similar INDe test article material
• Manage and direct on-site pilot plant staff and operations
• Oversee lab start-up and setup including organizing vendor installations instrument inspections, training sessions and general lab safety
• Ensure adequate material supplies for scale-up activities
• Maintain equipment maintenance schedules, including certifications and preventative maintenance
• Manage vendor relationships, all lab services (waste pick-ups, dry ice deliveries, alarm system, shipping) and permitting process

Qualifications:

• PhD in Engineering or Biology with 5+ years of experience or BS/MS with 10+ years of experience
• Experience in upstream or downstream process development is essential for the successful applicant
• Lab operations experience is required
• Experience with bioreactor operations and tech transfer for clinical products is required
• Ability and desire to work in a fast-paced, start-up environment
• Strong collaboration and team-working skills
• Strong communication, interpersonal and organizational skills
• Proven ability to work independently and effectively plan and organize work activities and prioritize task completion to meet schedules and deadlines

Title: Director, Patient Care Program Management

Reports to: Executive Director, Patient Care

Department: Patient Care

Location: St. Louis, MO (field-based)

Job Requisition #: GA-PC100

Summary

Provides leadership in the development and maintenance of patient care delivery systems to ensure desired outcomes. Works closely with the Specialty Pharmacy Services Provider and patients, as well serves as a patient care liaison to the Sales and Management Team.  This position is a field-based position within the Patient Care Department.

 Responsibilities

The Director, Patient Care Program Management role will have direct access to Specialty Pharmacy Services Provider resources and has primary responsibility for oversight and management of the following:

• This individual is responsible for closely monitoring the disposition of patients as patient referrals are received and implement and monitor compliance initiatives.
• The necessary exchange of information to ensure patients have access to the therapy as prescribed by their health care providers
• Assisting Patient Assistance Program recipients in their transition
• Oversee shipment information from consented patients to ensure compliance is optimized
• Effective education to patients/providers including one to one personalized support for the patient and family when needed
• Develop and lead lab testing program in collaboration with internal departments that results in optimum patient care
• Key contributor to patient quarterly newsletters

• Contribute to the development of strategies and tactical plans in support of advocacy opportunities for specific disease areas of interest
• Generate appropriate budgets and monitor expenditures, revising spending as needed. Provide periodic reports and analyses to management
• Serve as an internal resource regarding patient care and advocacy
• Partners with others on the team to support the establishment and implementation of the advocacy philanthropic support

Essential Functions

• Is the primary interface between the Specialty Pharmacy Services Provider, program patients, physicians and patient advocacy groups and is responsible to ensure quality services are delivered to patients.
• Educate patients and caregivers on importance of adhering to physician orders including but not limited to dosing and laboratory testing.
• Collaborate with the pharmacy team to support patient delivery and notification choices.
• Oversee Hub Counselor Education to optimize knowledgeable patient interactions.
• Drive resolution between physicians and Specialty Pharmacy Services Provider clinical appeals/payer team, when appropriate, for treatment approvals.
• Collaborate with Specialty Pharmacy Services Provider Pharmacist to improve patient adherence efforts and provide thorough new patient counseling.
• All other duties as assigned.

 Qualifications

• Bachelor's degree or equivalent combination of relevant education and applicable work experience.
• Registered Nurse -- preferred.
• Minimum 7-10 years Specialty Pharmacy/Hub Services Experience.
• Experience working with patient consumers in a rare disease specialty.
• Analytical, creative and interpersonal skills essential.

Specific Skills

• Positive Attitude and Energy -- Exhibits an upbeat attitude, a genuine interest in their duties and a sense of humor. Energizes other and heightens morale through her/his attitude.
• Communication Skills -- Possesses the ability to develop and articulate ideas and information that generate understanding and creates a climate that motivates and encourages others to participate.
• Innovator -- Transforms creative ideas into original solutions that positively impact the company's performance.
• Highly Principled -- Proves to be a professional of unquestionable integrity, credibility and character who demonstrates high moral and ethical behavior.

Working Conditions

This is a field-based position with preference for individual to be based in the St. Louis/Chesterfield Area, as site visits to the Specialty Pharmacy Services Provider will be necessary.  Some additional travel may also be required.

About Retrophin:  Retrophin is a biopharmaceutical company focused on discovering, developing and marketing innovative therapies for debilitating and often life-threatening diseases.  We are dedicated to working in areas in which the biopharmaceutical industry has, to date, had limited interest or effectiveness.  We maintain a focus on patients, working with doctors and patient advocacy groups and seeking to understand their distinct needs. 

Retrophin, Inc. is an EEO/AA/Veteran/Disability Employer