MSAT Senior Associate (Tech Transfer)

MSAT Senior Associate (Tech Transfer)

Bloomington, Indiana, United States

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines which are all directly injected into patients worldwide. As such, there is a strong emphasis on quality and continuous improvement at Simtra. We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging. Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

Why join Team Simtra? Because we:

Make it HAPPEN We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER We work as one, respecting each voice and tapping into our unique strengths across teamsso we can solve problems in new ways.

Make it RIGHT We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.

Make it COUNT We take pride in our day-to-day work, knowing the impact we make taking on challenges big and small to improve patient health.

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:

• 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

Disclaimer

This 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.

Equal Employment Opportunity

Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

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