About the Role:
- 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, DNASC, 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 tech transfer efficiency and capability.
- 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 up to 20% travel, primarily to customer sites and conferences.
About You:
- Advanced degree (MSc or PhD) in a relevant scientific or engineering discipline (e.g., Biochemical Engineering, Chemical Engineering, Biotechnology, Biochemistry, Biology).
- Minimum of 5 years of experience in the biopharmaceutical or life sciences industry, with at least 2 years in an alliance role or technical sales role for cell line development, technology transfer, process development, or manufacturing sciences within a CDMO or pharmaceutical/biotech company.
- 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.