This role:
The MSAT Senior Associate is part of a team of experienced pharmaceutical professionals responsible for the technical onboarding and process development of new drug product projects at BPS. This includes designing the process(es) required for the new project. The MSAT Senior Associate will work closely with a cross-functional group consisting of Program Management, Sales, Supply Chain, Process Validation, Research and Development (R&D), and others, during development and transfer of new projects to Simtra. This position reports to the Sr. Manager, Technical Transfer.
The responsibilities:- Lead the onboarding and process development activities & tasks for the manufacture of new drug products, including the supporting development studies.
- Serve as the lead technical expert among a cross functional team
- Lead the cross functional team through technical activities, development studies and clinical and/or PPQ batches
- Create Technical Transfer documents supporting this goal (Tech. Transfer Plan, Process development studies (i.e. mixing studies, filtration studies, purge studies, etc.), Demonstration batch records, GMP clinical/PPQ master batch record)
- Heavy participation / co-lead with Process Validation representative on PPQ strategy and protocol development
- Lead during hand-off to the commercial team following PPQ batches
- Provides technical support to daily Manufacturing operations. The position is visible on the Manufacturing floor, resolves issues during manufacturing and leads process improvement activities.
- Conduct deviation (DEV) investigations without assistance, as well as creation, ownership and implementation of Corrective Actions/Preventive Actions (CAPA)
- Change Control Management (CCM) owner and impact assessment
- Ownership of fill volume dosing qualifications (FVOQ)
- Critical evaluation of product impact and responsible for advising if product meets release criteria and regulatory requirements
- Grade A/B gowning qualification. Will enter Grade B areas for Batch support
- Participates in new project reviews to determine acceptable fit at Simtra
- Reviews Master Batch Records of junior colleagues and provides guidance
- Independently represents Simtra in regulatory, client and internal audits as product/process Subject Matter Expert (SME). Ownership of audit responses and related CAPAs.
- Participates independently in client calls and on-site visits to discuss and set strategy for projects and issue resolutions
- SOP owner & process SME
- Trained and will perform filter troubleshooting
- Develops and presents in-depth SME courses on pharmaceutical industry topics
- Mentors new hires in MSAT/Technical Services and helps with training and on-boarding
Required qualifications:- Bachelor's degree required, preferably in a science or engineering related field.
- Requires in depth knowledge of systems and equipment, including: scales, mixing systems and mixing monitoring methods, aseptic formulations, fill volume limit setting, disposable formulation technology, homogeneity testing, control charting, identification and response to trends.
- In-depth expertise in aseptic processing, sterile filtration, and clinical manufacturing and/or Process Validation
- Five (5) years pharmaceutical manufacturing experience, with a minimum of 3 years of applicable MSAT/Tech Transfer/Process Development experience.
- Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, MiniTab, Trackwise, etc.)
Physical / safety requirements:- Duties will require overtime work on occasion, including nights and weekends
- Use of hands and fingers to manipulate office equipment is required
- Position requires sitting for long hours but may involve walking or standing for periods of time.
- Must be able to qualify for Grade A/B area gowning. Grade A/B access may involve standing for periods of time.
- Must be able to wear applicable personal protective equipment (PPE).
In return, you'll be eligible for[1]
:- Day One Benefits
- Medical & Dental Coverage
- Flexible Spending Accounts
- Life and AD&D Insurance
- Supplemental Life Insurance
- Spouse Life Insurance
- Child Life Insurance
- 401(k) Retirement Savings Plan with Company Match
- Time Off Program
- Paid Holidays
- Paid Time Off
- Paid Parental Leave and more
- Adoption Reimbursement Program
- Education Assistance Program
- Employee Assistance Program
- Community and Volunteer Service Program
- Employee Ownership Plan
- Additional Benefits
- Short and Long-Term Disability Insurance
- Voluntary Insurance Benefits
- Vision Coverage
- Accident
- Critical Illness
- Hospital Indemnity Insurance
- Identity Theft Protection
- Legal and more
- Onsite Campus Amenities
- Workout Facility
- Cafeteria
- Credit Union
[1] Current benefit offerings are in effect through 12/31/26
DisclaimerThis job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job. It may not be inclusive of all the duties and responsibilities of the job. Simtra reserves the right to make modifications based on business requirements.
