Provide expert technical guidance on tech-out evaluation design, CLD planning, scale-up, optimization, and troubleshooting for various biopharmaceutical manufacturing processes (e.g., mammalian cell culture, purification, analytical methods, and viral vector production).
Work cross-functionally with internal departments (CLD, DNA Assembly, Process Development, Analytical Development, Quality, Facilities, Business Development) to ensure project success.
Oversee the preparation and review of critical documentation, including tech transfer plans, protocols, CLD reports, cell history documentation, and drug master filings.
Develop and implement standardized tech transfer procedures, protocols, and best practices.
Work with functional leads and teams to drive the implementation of new technologies and innovative approaches to enhance the efficiency and capabilities of tech transfer.
Occasionally support other programs within the Strategic Alliance team's purview, such as CHO Edge or RNA Edge portfolio projects.
Support customer inspections, audits, and related site visits at our site in Boston.
Represent the company at industry conferences, networking events, and in discussions with potential partners.
Stay abreast of industry developments, emerging technologies, and competitive dynamics to inform company strategy.
Collaborate closely with Business Development to assess new project opportunities and provide technical expertise.
This role is expected to involve approximately 20% travel, primarily to customer sites and our Boston headquarters.

Requirements

Advanced degree (MSc or PhD) in a relevant scientific or engineering discipline (e.g., Biochemical Engineering, Chemical Engineering, Biotechnology, Biochemistry, Biology)
Minimum of 10-12 years of experience in the biopharmaceutical or life sciences industry, with at least 1-3 years in a leadership role focused on cell line development, technology transfer, process development, or manufacturing sciences within a CDMO or pharmaceutical/biotech company.
Deep technical expertise in the genetic medicines field, specifically viral vector (AAV and LVV) with demonstrated experience leading tech transfers and effectively communicating complex technical data.
Strong understanding of the CHO biologics space including cell line development, process development, and comparative manufacturing constraints.
Direct experience in a CDMO environment is highly preferred, including customer-facing interactions or proven experience transferring technology between independent sites.
Strong leadership, communication, interpersonal, and presentation skills.
Excellent project management abilities, with a proven capacity to manage timelines, budgets, and resources effectively.
Knowledge of cGMP, FDA, EMA, and ICH guidelines.
Strong analytical, problem-solving, and decision-making skills.
Ability to work effectively in a fast-paced, dynamic, and collaborative environment.
Demonstrated ability to build and maintain strong working relationships with clients and internal stakeholders.
Strategic thinker with a proactive and results-oriented approach.

Benefits

stock options
eligibility for 401(k) plan
annual career development stipend
medical, dental, vision, life and disability insurances
flexible time-off
unlimited sick time

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

biopharmaceutical manufacturingcell line developmenttechnology transferprocess developmentviral vector productionanalytical methodscGMPFDA guidelinesEMA guidelinesICH guidelines

Soft Skills

leadershipcommunicationinterpersonal skillspresentation skillsproject managementanalytical skillsproblem-solvingdecision-makingstrategic thinkingcollaboration

Certifications

MScPhD