Simtra BioPharma Solutions · 18 hours ago
Sr. Manager, Technical Services
Bloomington, IN
Full-time
Onsite
Senior Level
5+ years expSimtra BioPharma Solutions is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. The Technical Services Building Cell Manager will manage a team responsible for Master Batch Records and provide technical support for Aseptic Manufacturing Operations, ensuring alignment with performance goals.
BiopharmaManufacturingMedicalPharmaceutical
Responsibilities
Work alongside Manufacturing, Engineering and Quality Cell leaders to fully own the performance for the operations in the Building Cell, including but not limited to:
Quality performance (batch release, non-conformance / right first time, corrective & preventive actions)
Manufacturing output (batch execution, run rates)
Serve as the primary technical resource for issue resolution during manufacturing operations
Drive creative technical improvements for the Building Cell leadership team
Ensure the Tech. Services team is aligned to support the Building Cell goals and performance
Fully engaged in initiatives across Technical Services functions for the Building Cell (Engineering batches, pre-PPQ demos, PPQs, CCOQs for new equipment, TS studies to drive improvements or generate data for investigations, Sterility Assurance Validations, Cleaning Validations, etc.)
This Technical Services Building Cell leader is not responsible for planning or executing the various technical studies owned by the centralized Technical Services groups (SAV, CV, Tech. Transfer, Process Validation, CSV). However, they will be engaged with the teams, aware of the activities needed by these groups, and facilitate getting the studies performed as necessary
Work with Manufacturing, Engineering and Quality to quickly resolve manufacturing issues
Manage and lead Tech. Services teams that own the master batch records (MBRs) and the Tech. Services floor support roles
Effectively operate in and mentor direct reports to lead cross-functional teams to complete process improvements
Maintain and develop direct reports to be Subject Matter Expert (SME) for technical processes applicable for the Building Cell
Ensure timely and thorough investigation of manufacturing anomalies to identify batch impact, root causes, and corrective/preventative actions, and approval of investigation findings and conclusions
Provide technical support during client and regulatory audits (individually or team); being a technical resource for plant initiatives
Approve technical study design and final study reports, e.g. MBR, PV protocols and summaries, TSS protocols and summaries, etc
Strategically set goals for team to support site goals and metrics. Drives to completion
Develops, coaches, mentors, and trains employees on necessary skills, including technical writing skills and client interfacing support skills
Facilitates career progression of direct reports
Qualification
Required
Requires a Bachelor's degree, from an accredited institution, preferably in a science or engineering field
Display a solid understanding of theories / practices utilized by other disciplines outside primary area of expertise
Minimum 5 years experience, with leadership experience preferred
Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: Veeva, Trackwise, etc.)
On-site regularly to support operations
Duties will require overtime work, 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 wear applicable personal protective equipment
Must be able to gown for Grade C/D environments
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
Employee Ownership Plan
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
Company
Simtra BioPharma Solutions
Simtra BioPharma Solutions is a pharmaceutical company that manufactures injectables and clinical supplies.
1001-5000 employees
H1B Sponsorship
Simtra BioPharma Solutions has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2024 (5)
Funding
Current Stage
Late StageTotal Funding
$0.5M2024-12-19Grant· $0.5M
Leadership Team
M
Mike Schaefers
Chief Commercial Officer (CCO) & Head of Business Development
Recent News
Inside INdiana Business
2025-09-23
Company data provided by crunchbase