Aseptic Observer Program Lead

Simtra Bio Pharma 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  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.

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 Aseptic Program Observer Lead is a member of the Quality Assurance Team reporting directly to the Associate Director of Quality Assurance. The Quality Manager, Aseptic Observation Program Lead, is responsible for designing and implementing quality systems and training program required to support the Aseptic Observation program, ensuring quality oversight of aseptic filling operations. In addition, the Aseptic Program Observer Lead is expected to partner with Quality Assurance Line Operations (QALO), operations leadership, training leadership, and the Contamination Control Strategy Team.

The Aseptic Program Observer Lead is expected to contribute to an environment where teamwork and productivity are encouraged, and safety, identity, strength, purity and quality (SISPQ) are reflected in the finished product.

Responsibilities:

• Design and continuous improvement of the Aseptic Observer Program (aseptic manufacturing quality oversight)
• Improve and standardize the QALO training program, including incorporation of industry and regulatory intelligence
• Develop strong partnership with QALO cell teams, manufacturing training, sterility assurance, QC microbiology and other stakeholders in program
• Organize collected data from Aseptic Observer Program, analyze trends, lead cross functional review meetings, and make necessary improvements with operations leadership based on observations
• Act as member of Contamination Control Strategy team
• Present aseptic observation program data to site and executive leadership in management review forums, including trending and improvements made
• Hire, train and develop QALO trainers

Required qualifications:

• Bachelor's Degree in scientific or related discipline required
• Minimum 5 years of experience in a pharmaceutical or biotech industry required
• Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: D365, Veeva, etc.)
• Ability to work in sterile environment with aseptic gowning requirement

Preferred qualifications:

• Excellent oral and written communication skills
• Previous technical writing experience including documentation, Change Controls, CAPAs, SOP, Regulatory observation responses
• Deviation management, review and writing

Physical / safety requirements:

• Must be able to sit and stand for extended periods of time.
• Must wear appropriate personal protective equipment as applicable.
• Duties may require overtime work, including nights, holidays and…