We are excited to announce the formation of the Advanced Manufacturing Partnerships Division (AMPD), which brings together the Nucleic Acid Solutions Division (NASD) and BIOVECTRA Inc., a part of Agilent. This new division aims to align advanced manufacturing capabilities, expertise, and resources to foster greater innovation and operational excellence.
As part of AMPD, you will have the opportunity to work with cutting-edge technologies and collaborate with a team of dedicated professionals committed to making a significant impact in the industry. Join us in our mission to revolutionize advanced manufacturing and contribute to the success of NASD and BIOVECTRA.
The BIOVECTRA Director, Manufacturing Operations will lead a multi-shift operations of +100 employees, overseeing fermentation, downstream processing, and technology transfer while driving continuous improvement, operational excellence, compliance, and regulatory standards. They will ensure that processes are developed, qualified, validated, and manufactured for microbial-derived active pharmaceutical ingredients (API) such that they are compliant with cGMP, ICH, and FDA guidance documents which reflect the current requirements in the pharmaceutical industry. This position will be responsible for leading the implementation of multiple technical transfer and process development projects and for coordinating and facilitating interdisciplinary team efforts toward common site goals.
ESSENTIAL FUNCTIONS:
- Leading the manufacturing group to ensure production efficiency, product output, product quality, customer service, and cost-effective management of resources.
- Developing and leading a team of high-performing managers focused on microbial-derived API manufacturing, on-time delivery of customer expectations, and cost management.
- Ensuring cross-departmental communications are maintained to achieve manufacturing goals.
- Overseeing and coordinating, in conjunction with the Product Development team, Engineering and other stakeholders, the transfer and scale-up of specialized trial projects; including development of budgets, timelines, and quality guidelines.
- Developing strategic and operating plans to ensure the company has the appropriate resources to support current forecasted business and projected growth.
- Leading multiple operations with annual revenues in excess of $50 million.
- Providing coaching and guidance; ensuring the company maintains its leadership position in the industry through the development of the management team.
- Leading the management team to develop and implement plans which strengthen the operational infrastructure of the people, processes, and profit to achieve the rapid growth objectives of the organization.
- Assessing progress made by each operating unit to ensure each is working toward a common goal for the organization.
- Accountability for prompt resolution of manufacturing issues which are likely to impact customer satisfaction and overall company operations.
- Accountability for the operating budget for the area.
- Approving documents/procedures/SOPs generated for the manufacturing area.
- Interacting effectively at multiple levels in support of customer relationships.
- Participating in regulatory inspections and internal audits.
- Providing timely and complete performance reviews of managers. Identifying skill or knowledge gaps in employee skill sets and determining the best form of training to achieve optimal results and capitalize on employee talents.
- Adhering to and enforcing BioVectra’s Health and Safety Policy as outlined in CP0010 Occupational Health and Safety Policy, Statements of Principle, and Responsibilities.
This is an onsite role at our Prince Edward Island, Canada location. Relocation is provided.
Qualifications:
- Undergraduate Degree or equivalent experience, Bachelor of Science in Chemistry and/or Bachelor of Engineering Degree preferred.
- 10+ years experience managing multiple levels of management/direct reports and indirectly managing a large workforce in the chemical or pharmaceutical industry.
- Knowledge of microbial-derived API process design, startup, and implementation.
Preferred Skills / Qualifications:
- Demonstrated leadership, strong project management experience with cross-functional team direction skills.
- Excellent verbal, written, and presentation skills.
- Excellent problem-solving and analytical skills.
- Knowledge of current Good Manufacturing Practices (cGMP).
LEADERSHIP COMPETENCIES:
- Leverage Diversity
- Develop Others
- Facilitate Transformation
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