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Company Confidential – Boston, MA
Full Time – Permanent: Hybrid for East Coast applicants
The Opportunity
A well-funded clinical-stage biotech in Boston seeks a Head of Drug Substance to serve as an experienced leader in biologics development. This role reports to the SVP of Technical Operations and will play a key part in driving the portfolio forward from early process development through late stage, including process characterization, validation, and commercialization. If your strengths include laying the groundwork for strategy and deep expertise with development including late stage and commercialization measures, exceptional relationship building in a technical setting, management of internal reports and vendors, and the ability to collaborate cross-functionally to ensure efficient and effective development efforts, read on!
Key Responsibilities
● Lead drug substance team through preclinical and clinical development to commercialization across pipeline, with end-to-end responsibility of drug substance process development and technical support.
● Drive, build, and enhance strategic relationships with CDMOs and other partners to advance drug development pipeline.
● Provide strategic and operational oversight, content creation of all regulatory documents, and requests for information.
● Partner cross-functionally throughout the organization including program teams, research, clinical development, medical affairs, new product planning, regulatory affairs, and corporate communications.
● Represent team holistically internally and externally as needed with due diligence, regulatory interactions, indication expansion, technology and innovation opportunities, project team, and portfolio review committee activities.
● Develop, own, and execute against the operational budget pertaining to drug substance including manufacturing and process development.
The Person
● PhD in biochemical engineering, chemical engineering, biochemistry, or relevant discipline with 12-15 years industrial bioprocess development/scale-up and manufacturing experience OR BS/MS with minimum of 15-20 years of qualifying industrial experience. The ideal candidate will have extensive cell line and upstream process development experience.
● 5 years’ direct management experience is required.
● Strong leadership skills with experience defining the vision for the patient affairs function - including strategic planning and supporting the development and growth of team members.
● Proven track record of building trusting, meaningful relationships with key stakeholders, cross functional organizations and CDMO vendors and partners.
● Full familiarity with the legal, regulatory, and compliance environment, including deep knowledge of guidelines and best practices for drug substance development.
● Highly collaborative and able to successfully develop and maintain strong working relationships cross-functionally with colleagues and with external stakeholders.
Location
This position is based in Boston, MA. Hire must be available to travel 25% of the time (domestic and international), including monthly visits to the Boston office.
Contract/Part-Time 30-35 hrs/week
The Opportunity:
We’re seeking a Research Associate or Senior Research Associate (RA/Sr. RA) to join a dynamic and growing gene delivery company. This individual will play a key role in supporting polymer synthesis efforts for various delivery applications. The RA/Sr. RA will collaborate closely with senior leadership and cross-functional partners, gaining valuable exposure to both internal R&D and external collaborations.
Key Responsibilities:
Your Background:
Location
This position is based in Boston, MA and is fully onsite.
Company Confidential – Greater Boston
Full Time
The Opportunity
Genepool Networks is proud to partner with an emerging biotech team developing a new generation of medicines to treat oncology and other immunological targets with unmet needs. This is a newly created role reporting directly to the Chief Medical Officer. The Director/Senior Director of Clinical Science will be a key member of the clinical development team and a major contributor to the development and execution of the clinical strategy for Clinical Programs in Oncology and other therapeutic areas, providing clinical research support for multiple programs.
Company Confidential – Greater Boston
Full Time
The Opportunity
Our client seeks a Medical Director or Senior Medical Director to join a growing team in support of an impressive clinical pipeline poised to disrupt the market, addressing diseases with significant patient needs. This is a newly created position within a growing organization led by a seasoned team. Our client has developed an unmatched culture built on scientific rigor and the passion to make an impact in patients’ lives.
Key Responsibilities
● Collaborate with discovery teams providing strategic input for Ph1 clinical programs.
● Lead late-stage clinical trials (protocol design, data analysis, medical monitoring).
● Expertise in rheumatology, immunology, or a related field.
● Collaborate with regulatory leaders to develop and execute submission strategies, INDs, NDAs, etc.
● Experience developing strong partnerships with academic advisors, principal investigators, patient groups, regulatory authorities, and industry collaborators.
● Design and implement global clinical development plans on cross-functional teams.
The Person
● Minimum of 2 years of industry experience.
● MD, clinical training in Rheumatology is preferred.
● Hybrid work environment.
● Legally authorized to work for any US employer.
Location
The position is based in the Greater Boston area. Candidates must be willing and able to commute to the office for onsite responsibilities and be authorized to work in the US indefinitely.
Company Confidential – Bay Area
Part-Time, Temporary
The Opportunity
Genepool Networks is proud to partner with an innovative biotechnology company in the Bay Area utilizing natural product chemistry to address unmet patient needs. This team is seeking a Protein Science Intern with a background in protein QC methods. In this role, you will characterize antibodies and antibody-drug conjugates to advance treatments that will overcome the limitations that come with cancer therapies that are currently available to patients.
Responsibilities range from routine testing using HPLC and other protein quantification techniques, to determining ways to optimize throughput and timelines for QC assays.
The need for this support is immediate, and the role is a 1-year commitment. While some of the hours will be flexible throughout the week, the right hire will have Mondays, Wednesdays & Fridays available to fit the timing of the experiments being done internally.
Key Responsibilities
• Perform analytical characterization of antibodies and antibody drug-conjugates to support in vitro and in vivo studies.
• Ensure the highest standard of quality in antibody and antibody drug-conjugate production in alignment with QC criteria.
• Analyze experimental data and interpret results to guide decision-making processes.
• Proactively identify workflow limitations and implement solutions.
• Collaborate with a diverse team to answer scientific questions and deliver quality and timely findings in support of therapeutic candidate advancement.
• Effectively communicate findings and interpretation of results.
• Comply with health and safety policies and general laboratory practices.
• Maintain organized data from experiments.
The Person
• Bachelor’s or master’s degree in protein sciences or relevant field with 1-2 years hands-on experience in the biotech industry.
• Hands-on experience in analytical methods for protein evaluation: HPLC required. FPLC, SEC, IEX, HIC, octet/SPR, LC-MS, SDS-PAGE, and/or endotoxin detection) are highly preferred.
• Experience with multicolor flow cytometry, ADCC/CDC assays, and/or ELISA is a plus.
• Strong desire to continue seeking new technological innovations supporting laboratory work.
• Excellent problem-solving skills, with the ability to troubleshoot experiments and propose innovative solutions.
• Effective communication and collaboration skills, with the ability to work independently and as part of a multidisciplinary research team.
• Effective communication and collaboration skills, with the ability to work independently and as part of a multidisciplinary research team.
• Self-motivation, initiative, and boldness to dive into a fast-paced new startup.
Location
The position is based in Menlo Park, CA. Candidates must be willing and able to commute to the company for onsite responsibilities.
Genepool Networks is an equal opportunity employer. All qualified applicants will
receive consideration for employment without regard to race, color, religion, sex,
sexual orientation, gender identity, national origin, disability, or veteran status.
We encourage applications from candidates of all backgrounds and experiences.
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