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Senior Engineer, MSAT
4 months ago
Bionova is a rapidly growing, biologics CDMO focused on developing and manufacturing recombinant protein products using mammalian cell culture processes. Our business success is built on bringing together top scientific talent, arming them with the best available tools, and setting them loose in an agile, energized culture focused on solving difficult client problems. Because our success depends on our ability to exceed our clients' expectations, we look for candidates with an innate desire to serve. Adaptability and an interest in transformative action are also common attributes among our team. Bionova became a subsidiary of Asahi Kasei Medical in May 2022, a division of Tokyo-based Asahi Kasei Group. This acquisition has enabled Bionova to greatly accelerate growth of the business, both in capacity of current service offerings and expansion into new service offerings.
Company:
Bionova Scientific LLC
Job Description:
Company Summary:
Bionova is a rapidly growing, biologics CDMO focused on developing and manufacturing recombinant protein products using mammalian cell culture processes. Our business success is built on bringing together top scientific talent, arming them with the best available tools, and setting them loose in an agile, energized culture focused on solving difficult client problems.
Because our success depends on our ability to exceed our clients' expectations, we look for candidates with an innate desire to serve. Adaptability and an interest in transformative action are also common attributes among our team.
Position Summary:
The Senior Engineer, in Manufacturing Science and Technology (MSAT) will actively contribute to the manufacturing and technology transfer projects at the Bionova Scientific West Warren Fremont location. As part of the MSAT group, you will have opportunities to work on and specialize in expertise of Upstream (US) Cell Culture and/or Downstream (DS) Purification. Position will work with multiple functional teams at Bionova to lead GMP Manufacturing readiness activities, tech transfer, and support successful completion of client manufacturing projects.
Essential Duties and Responsibilities:
- Management of GMP manufacturing readiness and tech transfer tasks as part of new product introduction (NPI) for client projects. Candidate will work with Bionova functional teams to ensure readiness of raw materials, documents, equipment, processes and facilities activities.
- Generate and maintain GMP material bill of materials (BOM). Activities will involve using ERP system (e.g. QAD).
- Ensure facility fit and tech transfer process working with internal process development teams, vendors, and clients.
- Support tech transfer of processes using single-use equipment including but not limited to: bioreactor, chromatography, depth filtration, VD and/or TFF.
- Support US or DS equipment troubleshooting, authoring deviations, corrective actions (CAPA), and change controls.
- Author and review technical documents such as tech transfer protocols and reports, experimental plans, production batch records, training materials, manufacturing SOPs, and regulatory filing documents per project needs.
- Lead meetings and communicate effectively with internal stakeholders. Present findings in external client meetings.
- Contributes to quality activities such as investigations, authoring deviations, CAPAs, and Change Controls.
- Undertake and successfully execute additional projects and assignments to refine and improve workstreams and systems.
- Maintains own training within compliance and trains other upon completion of trainer qualification.
- Documents work according to cGMP and cGDP.
- Adheres to established regulations and follows cGMP established by site.
- This position required to work in a lab/office setting. The role requires walking, standing, stooping, kneeling, and crouching. The employee must occasionally lift and or move up to 20 pounds independently.
- BS, MS, or PhD in Engineering, Life Sciences, or related discipline with 9+ years of relevant experience, or combination of experience and relevant advanced degree, preferably in biopharma manufacturing role.
- Hands-on experience working in a GMP manufacturing facility with either upstream fermentation equipment (e.g. single-use bioreactor) or downstream purification equipment (e.g. chromatography).
- Experience with process development, process characterization and/or tech. transfer processes.
- Working knowledge of cGMP compliance as it pertains to procedures, processes, and manufacturing.
- Experience with process monitoring software and equipment software (e.g. UNICORN, Pi Historian).
- Experience with ERP systems (QAD).
- Creative thinker that can identify better and more efficient methods to address issues and gaps.
- Demonstrate ability to work independently, organize, and communicate effectively.
- Ability to prioritize assignments and to manage multiple projects simultaneously.
- Bionova offered Benefits and Program
Healthcare, Dental, and Vision insurance: Bionova offers health benefits at a subsidized rate.
Life Insurance and Disability Program: Life insurance is offered at 2x of annual base pay. Life insurance benefits start from the first day of employment. Disability programs are fully covered by Bionova; a waiting period may apply as per company policy.
Retirement Plan (401K) Up to 8% of Employer Match.
Paid time off up to 2 weeks.
Holiday: Ten (10) holidays each year.
As an equal opportunity employer, Asahi Kasei believes a diverse workforce will provide us with the ability to continuously support the changes in the economy, society, and environment.
