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 Director of Operational Execution will be responsible for driving operational efficiency and quality improvement initiatives across our sterile manufacturing facilities. This strategic leadership role will focus on implementing best practices, enhancing production processes, and ensuring compliance with industry standards to meet client expectations. The ideal candidate will possess a robust background in sterile manufacturing, a strong understanding of regulatory requirements, and a proven track record in leading continuous improvement efforts. This position is remote, and it reports to the Vice President of Operational Execution.The responsibilities:
- Leadership and Strategy:
- Develop and implement the operational execution strategy focusing on production performance, capacity expansion, and client satisfaction - in alignment with organizational goals
- Lead and mentor a team of professionals, fostering a culture of accountability and high performance
- Process Improvement: Identify and implement Lean and Six Sigma methodologies to streamline manufacturing processes, reduce lead times, and enhance overall efficiency
- Oversee the execution of continuous improvement initiatives, ensuring alignment with client and regulatory requirements and quality standards
- Quality and Compliance:
- Ensure adherence to FDA regulations, cGMP guidelines, and relevant industry standards across all manufacturing processes
- Collaborate closely with Quality Assurance and Quality Control teams to maintain rigorous quality systems and drive compliance in all operations
- Client Engagement:
- Key point of contact for client operational needs, ensuring alignment of manufacturing processes with client specifications and expectations
- Gather and analyze client feedback to inform process improvements and enhance service delivery
- Training and Development:
- Design and implement training programs to develop operations and quality personnel to deliver on company objectives as excellence and continuous improvement among staff
- Partner with the Learning and Development team to establish the new training center for a collaborative environment that values innovation, teamwork, and employee development
- Cross-Functional Collaboration: Partner with R&D, Supply Chain, Sales, and Project Management teams to ensure alignment between operational capabilities and client demands
- Lead cross-functional projects to drive continuous improvement and optimize resource allocation
- Reporting and Analysis:
- Develop and present reports on operational performance, key improvement initiatives, and strategic projects to senior management and clients
- Utilize data analytics to identify trends, insights, and opportunities for operational enhancement
Required qualifications:
- BS in Engineering, Life Sciences, Operations Management, or a related field; MS degree preferred
- 10+ years of experience in pharmaceutical/biotech industry, with at least 5 years in a leadership role focused on operations or quality within a client servicing organization
- Contract manufacturing experience preferred
- Strong knowledge of sterile manufacturing processes and regulatory requirements (FDA, cGMP, etc.)
- Proven experience with Lean, Six Sigma, and other continuous improvement methodologies
- Excellent analytical, problem-solving, and decision-making skills
- Strong interpersonal and communication skills, with the ability to effectively engage and influence stakeholders at all levels, including clients
- Experience managing cross-functional teams and projects in a dynamic manufacturing setting
- Experience with Quality Management systems Veeva Vault and Trackwise
- Experience with data analytics software such as PowerBI, Minitab, Confluence, or JIRA
In return, you'll be eligible for [1]:
- Day One 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
- Additional Benefits
- 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
[1] Current benefit offerings are in effect through 12/31/24DisclaimerThis 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 OpportunitySimtra 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. EEO is the Law EEO is the law - Poster Supplement Pay Transparency PolicyData PrivacyTo learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy: