Operations Specialist - Clinical Manufacturing

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 teams-so 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 Operations Specialist - Clinical Manufacturing manages the day-to-day operations of the clinical production area, including the hiring, training, and work allocation of the manufacturing Operators and Process Specialists. The role provides direct technical / process support as a Subject Matter Expert (SME) for the clinical line and transfer of products to the area.

The position reports directly to the Director of Development and Pre-Clinical Services (DPCS) Bloomington, and functions as a management designee based on business needs. The position requires interaction across multiple departments, including heavy engagement and communication with DPCS, various Quality functions, and all Technical Services teams, as well as with clients and regulatory agencies. Communication skills, experience with root-cause-analysis tools, and understanding of aseptic manufacturing are a must.

The responsibilities :

• Function as a lead for the operations of the Clinical area related to scheduling, review / approval of investigations / procedures / CCM / LMR and MSS, and daily production decision-making. Assumption of at least 20% time "on the shop floor" per week.
• Develop a solid understanding of manufacturing processes / equipment - evolve into SME across multiple areas (including Preparation, Filling, Formulation, Capping, and Lyophilization) supporting the Bloomington Clinical program.
• Partner with DPCS, Commercial Project Management, and Technical Services' Technical Transfer groups to successfully evaluate and transfer products into the Clinical production area.
• Partner with the site Quality organization and work hand-in-hand with the Quality Head DPCS to ensure compliance as well as flexibility of operations.
• Partner with EHS to ensure the highest level of safety and sustainability for the area.
• Develop a solid understanding Lean / Six Sigma tools : SPC, CPk, Statistics, Pareto, Fishbone, 5-Why's, Utilize these tools to drive improvements to manufacturing processes and build a culture of continuous improvement throughout the DPCS Operations organization.
• Participate in and / or lead investigation / analysis teams to solve complex issues and determine root cause(s) and implement innovative, cost-effective corrective actions to prevent recurrence.
• Support team deliverables and maintain required
• Ability to create, manage and approve Master Change Control, Equivalency Forms and Work
• Coach / mentor and train Process Specialists and Production Operators on specialized skills / tasks.
• Successful operator qualification / media fill

The work environment :

Classified pharmaceutical environment wearing required gowning as shown in attached document. Must be able to work safely with materials required to produce pharmaceutical products, including chemicals, compounds, glassware and sanitization solutions.

Desirable qualifications :

Physical / safety requirements :

In return, you'll be eligible for [1] :

Medical & Dental Coverage

Spouse Life Insurance

Paid Holidays

Voluntary Insurance Benefits

Vision Coverage

Workout Facility

1] Current benefit offerings are in effect through 12 / 31 / 25

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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