This role:The Manufacturing Science and Technology (MSAT) role is part of a team of experienced pharmaceutical professionals responsible for the technical onboarding and process development of new drug product projects at Simtra. This includes designing the process(es) required for the new project. The Tech Transfer 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 is 100% onsite at the Bloomington facility and reports to the Sr. Technical Transfer Manager.
The responsibilities:- Lead the onboarding and process development activities for the manufacture of new drug products, including the supporting development studies
- Lead the cross-functional team through technical activities, development studies and PPQ batches
- Create technical transfer documents supporting this goal [Technical Transfer Plan, Process Development studies (i.e. mixing studies, filtration studies, purge studies, etc.), Demonstration batch records, 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 while being visible on the manufacturing floor and resolving issues during manufacturing
- Leads process improvement activities
- Independently conduct Non-Conformance Report (NCR) investigations and create, provide ownership, and implementation of Corrective Actions/Preventive Actions (CAPA)
- Change Control Management (CCM) owner and impact assessment
- Ownership of Fill Volume Dosing Qualification (FVOQ) documentation
- Critical evaluation of product impact and responsible for advising if product meets release criteria and regulatory requirements
- Participates in new project reviews to determine acceptable fit
- 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
- Standard Operating Procedures (SOP) owner & process subject matter expert (SME)
- Perform filter troubleshooting
- Develop and present in-depth SME courses on pharmaceutical industry topics
- Mentors new hires in Technical Services Department and helps with training and on-boarding
Required qualifications:- BS degree, preferably in a science or engineering related field
- 7+ years pharmaceutical manufacturing experience
- 3+ years of applicable Technical Transfer/Process Development experience
- 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
- Expertise in aseptic processing, sterile filtration, and Process Validation
- Microsoft Office Suite advanced proficiency Word, Excel, and Outlook
- Knowledge and ability to use enterprise software (JDE, BPLM, Minitab, Trackwise, etc.)
Physical / safety requirements:- Duties will require overtime work on occasion, including nights and weekends
- 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
- 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
- Short and Long-Term Disability 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
- Additional Benefits
- 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 12/31/24
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.
