-- -- Sr. Process Engineer---------- -- POSITION SUMMARY: The individual will be responsible to manage and lead technical issue resolution relating to biologics products or key major technical projects within External Operations with minimal oversight.-- The individual will be responsible for external production (clinical & commercial manufacturing) of drug product including process design, optimization, scale-up, technology transfer and validation. -- MAJOR RESPONSIBILITIES
List the primary job duties for the role
Estimate a percentage of time spent on each activity
Lead scale-up, technology transfer and production start-up activities.--Includes onsite presence at our contract manufacturing organizations
Support ongoing Drug Product manufacturing operations through process monitoring, trending and issue resolution. Identify and remediate risks.
Support the development of business processes and procedures such as data reviews, tech transfer protocols, and process control strategies
Drive process and program improvements through Change Controls, Investigations and-- Corrective Actions. Support regulatory filing updates.
-- -- *Performs role related duties and ad hoc projects as required -- EDUCATION AND EXPERIENCE Bachelor's Degree in Science, Engineering or similar Technical discipline with > 10 years relevant experience in high volume manufacturing and/or relevant environment likely to include:
Biologics Drug Substance, Drug Product manufacturing Clinical and 3rd party manufacturing
Advanced technical degree is advantageous. Experience with Operational Excellence, Lean or Six Sigma methodologies is preferred. -- QUALIFICATIONS: Technical Skills
Strong understanding of technical/scientific challenges as those apply to the production processes in both Drug Substance and Drug Product Manufacture Working knowledge of aseptic manufacturing operations, and/or drug product manufacturing with experience with lyophilization.-- The candidate also needs to have an excellent knowledge of CMC regulations, cGMP, sterility assurance techniques and FDA guidances Experience with technical transfer and validation of biologic manufacturing processes. Demonstrated understanding of the connection between compliance and manufacturing. Creating business proposals, statements of work and other business agreements Experience within a CMC team preferred
-- Other Personal or General Characteristics
Established track record with evidence of project management. Ability to foster and promote internal & external collaboration. Ability to work and get results through matrixed teams Outstanding attention to detail, critical thinking and problem solving skills. Excellent interpersonal and communication skills. Speaks clearly and persuasively in positive or negative situations; listens and gets clarification. Responds well to questions; Demonstrates group presentation skills; Participates in meetings. Balances team and individual responsibilities.
-- TRAVEL REQUIREMENTS:
Ability to travel to various meetings or client sites, including overnight trips. Some international travel may be required. Position requires up to 25% travel.