Assistant Manager, Parenteral Manufacturing Operations
2 weeks ago
Position Title: Assistant Manager, Parenteral Manufacturing Operations
Department: Production
Reports to: Vice President of Operations
Location: Bloomington, IN (Onsite)
Employment Type: Full-time, 40 hours/week, 1st shift, Exempt
Position Summary:
The Parenteral Product Development and Manufacturing Science division is essential to Singota's expertise and vision in supporting clients as they advance new therapeutic agents through the product lifecycle.
The Assistant Manager, Parenteral Manufacturing Operations serves as a key leader and technical authority responsible for overseeing transfer activities that ensure the efficient and reliable production of selected parenteral product formats utilizing Singota's advanced manufacturing technology. This role, in collaboration with the team, will enhance and implement manufacturing science expertise across the entire parenteral operations spectrum, including formulation, filling, and inspection processes. The individual will act as a technical resource for internal stakeholders, focusing on analyzing equipment and process data, monitoring production metrics, drafting and executing protocols, and driving process improvements and root cause analyses. Regular interaction with manufacturing operations and engineering teams is expected to support daily operational needs.
Key Responsibilities:
- Facilitate appropriate transfer and scaling of clinical materials from clients to internal manufacturing systems.
- Lead the successful integration of new processes and product formats into manufacturing.
- Ensure timely completion of technology transfer documentation to enable seamless execution.
- Drive the implementation of continuous improvement initiatives related to process transfers.
- Prepare and review essential technical documents, including Batch Records, Change Controls, Regulatory Submissions, Deviations, Validations, Protocols, Procedures, PFDs, and pFMEAs.
- Conduct assessments of incoming product and process knowledge relevant to new technology transfers.
- Provide insights and requirements for drug product development concerning materials in direct product contact.
- Support investigations, CAPAs, and change controls as assigned, including critical raw data reviews for key documents.
- Evaluate new technologies and applications for feasibility, business case, conceptual design, installation, and implementation.
- Assess necessary resources and timelines for executing client studies, designing process characterization studies, and leading the team to meet agreed milestones.
- Contribute to knowledge generation and integration across R&D and Operations activities, sharing insights internally and during client interactions.
- Establish metrics for tasks, performance, and deliverable status within Technical Operations, performing data analytics to convert results into actionable knowledge.
- Act as the department's subject matter expert in Parenteral Manufacturing Science, leading and developing a team focused on manufacturing support.
- Manage the MST department, fulfilling standard supervisory responsibilities, including employee mentoring.
- Participate actively in the Leadership Team.
- Oversee the department's budget.
- Provide ongoing support for developing executable protocols, ensuring accuracy in documentation, execution, and summarizing study outcomes.
- Assist Business Development and Client Services with new and repeat business opportunities.
- Engage in Client and Regulatory Audits and Inspections.
Essential Characteristics:
- Proven expertise in pharmaceutical sterile process development and fill/finish operations, particularly with isolators and robotic filling technologies.
- Experience in clinical development and manufacturing.
- Self-motivated with the ability to work independently and manage direct reports, demonstrating strong problem-solving skills.
- Exceptional experimental and technical writing skills, with experience in a regulated pharmaceutical environment.
- Strong commitment to outstanding customer service and teamwork.
- Excellent time management and organizational skills, with the ability to manage multiple priorities effectively.
- Outstanding communication and presentation skills, capable of engaging effectively with diverse audiences.
- PhD in Pharmaceutical, Biochemical, Chemical, Life Sciences, Engineering, or a related field with 5+ years of relevant experience.
- OR a Master’s degree with 7+ years of experience.
- OR a Bachelor’s degree with 10+ years of experience.
- 401(k) plan
- 401(k) matching
- Dental insurance
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Tuition reimbursement
- Vision insurance
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