Lead Scientist/Engineer, Manufacturing Science and Technology - Cambridge, MA
: $94,360.00 - $141,170.00 /year *
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Brammer Bio is a rapidly growing, dynamic gene therapy contract development and manufacturing organization that is seeking sharp individuals to bring the highest quality processes, products and testing to our clients. Our employees are committed to making a difference in our organization, for our client partners and the patients we serve. We are looking for top talent with proven competencies and strong character to join our team and help lead our organization into the future.
The primary responsibility of the Lead Scientist/Engineer is to support technology transfer teams for the late stage, PPQ and commercial manufacturing of viral vectors. The individual will serve as a process Subject Matter Expert (upstream, downstream or drug product fill/finish). This position requires close interaction with the MS&T colleagues, Project Management, Manufacturing, Quality Assurance, Quality Control, Process Sciences, Process Development, Engineering, Supply Chain and other departments. This role will focus on aspects of implementing and profiling robust, scalable and efficient manufacturing processes to produce late-phase human clinical trial and commercial gene transfer vector products.
Lead cross functional technology transfer teams for cGMP cell banking/DS/DP manufacturing of viral vectors. Collaborate with other sites or clients to ensure success of scale up/ process transfer. Ensure effective information flow, risk assessment, timeline execution, issue resolution and documentation for cross-functional teams. Includes leading the tech transfer facility fit gap assessment.
MST process lead on client programs as assigned, ensuring the materials, strategy and documentation are in place.
Collaborate with PS/PD/QC/QA to develop testing strategy for raw materials, start materials, intermediates, DS and DP
Author and maintain process control strategy documents throughout the lifecycle of a program
Author and maintain process risk assessment documents
Author PPQ protocols and reports. Oversee execution of PPQ and PPQ related activities
Support engineering teams on equipment selection, qualification, and start up activities.
Develop sampling plans with clients and incorporate them into cGMP batch documentation.
Monitor and trend process performance, including input and output parameters.
Investigate root causes of major deviations for cGMP manufacturing, and implement CAPA for major deviations
Identifying opportunities to improve systems and practices
Hire and develop direct reports (as applicable) in support of group, department, site, and corporate objectives. Provide feedback and coaching.
Work with counterparts in Brammer s Alachua Process Development and Cambridge Process Sciences, Manufacturing, Quality, Project Management teams etc. to facilitate technology transfer and project success.
Thermo Fisher offers an attractive benefit package to all full time employees which includes; medical, dental, and vision coverage, company paid Disability and Life Insurance benefits, and a 401(k) Plan with a generous company match. All full time employees are also provided with paid time off, paid company holidays, and an incentive bonus plan.
Thermo Fisher is an Equal Opportunity Employer and participates in eVerify.
Bachelor or advanced degree in Biochemical, Chemical Engineering or a related scientific discipline such as Chemistry or Biology.
B.S. with 8+ years experience, or Master s degree with 6+ years experience, or PhD with 3+ years experience.
Matrix leadership experience required.
Strong interpersonal and communications skills; written and oral. Ability to speak effectively before clients.
Ability to work both independently and as part of a team.
Ability to function in a fast-paced dynamic team environment and balance prioritize multiple projects
Expertise in late stage/commercial technology transfer and process validation biopharmaceutical/gene transfer vector manufacturing preferred.
Working knowledge of GMP and regulatory requirements of biopharmaceutical manufacturing.
Knowledge of cell and gene therapy vector production highly desirable.
Project management skills desirable
Ability to be hands-on
Ability to speak effectively before groups of customers.
Upstream: Technical expertise in upstream biopharmaceutical manufacturing and/or process development. Experience with adherent and suspension mammalian (HeLa, HEK, Vero) and insect (Sf9) cells. Knowledge of Stirred Tank Bioreactors (fed-batch and perfusion), flat stock technology including Cellstacks, Hyperstacks and iCellis and various platforms for vector production (transient transfection, stable producering cell lines, and helper virus technology) is strongly recommended. Experience with ATF and hollow fiber TFF highly preferred. Knowledge of at-scale downstream processes as well as applicable modern in-process analytics is desired.
Downstream: Technical expertise in downstream biopharmaceutical manufacturing and/or process development. Experience with filtration (dead end and tangential flow) and process considerations for scale up. Experience with various chromatography resins and membranes. Ability to operate various AKTA systems. Various platforms for vector production (transient transfection, stable producering cell lines, and helper virus technology) is strongly recommended.
Fill/Finish: Experience with automated fill finish line and controlled isolator environment considerations. Knowledge of formulation and storage conditions. Utilizes manufacturing processes knowledge and investigational skills to identify and resolve manufacturing issues and drives continuous improvement in process operations.