Director, Manufacturing

Avecia Pharma; Milford (MA); On-site; USD 215,000 - 244,000; Full time

Job summary

Avecia Pharma site in Milford seeks a Director of Manufacturing to oversee all direct manufacturing activities, develop and implement procedures, and ensure data integrity and compliance. The role drives lean and 5S improvements across the department and partners with cross-functional teams to optimize operations.

Responsibilities include scheduling, budgeting, and ensuring timely delivery, while mentoring staff and leading organizational change to sustain continuous improvement in a GMP

Qualifications

• BS/BSc in sciences with extensive management experience.
• Experience leading biopharmaceutical manufacturing operations.
• Strong knowledge of GMP, CAPA, and data integrity practices.

Responsibilities

• Direct daily manufacturing operations to meet schedule on first pass.
• Establish KPIs to drive continuous performance and efficiency.
• Manage budgets and align expenditures with targets.
• Collaborate with departments to execute optimization projects.
• Ensure staff training aligns with global regulations for pharma compounds.

Skills

Leadership

Biopharmaceutical manufacturing

Lean Six Sigma

Budget management

Change management

Capacity planning

Regulatory compliance

Team development

Education

BS/BSc in sciences

Tools

Lean Six Sigma Certification

Job description

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The Director of Manufacturing oversees all direct manufacturing activities for the Milford site. The position is responsible for the development, implementation, maintenance, and oversight of manufacturing systems and activities for the site. The director assures compliance to prescribed procedures and strict adherence to data integrity policies. The position will also oversee the development and implementation of procedures for manufacturing operations, including implementing lean and 5S approaches for the department.

Key Responsibilities:

• Directs daily operations to assure all manufacturing activities are delivered to schedule right the first time.
• Establish and monitor metrics and KPIs to drive continuous performance and operational efficiencies within the manufacturing group to assure budgetary expectations are met.
• Managing budgets for the manufacturing group and rationalize expenditure against financial targets.
• Actively partner with stakeholder departments such as Operational Excellence, Process Development, Facilities, Quality Operations, Project Management, and Engineering to align and successfully execute optimization projects and continuous improvement efforts.
• Ensure that the knowledge and training for manufacturing staff aligns with evolving global regulations and guidance for pharmaceutical compounds (in general) and oligonucleotides (in particular), and develop appropriate solutions when gaps are identified.
• Accountable for ensuring that teams deliver against appropriate timelines, including deviation and CAPA completions in a timely manner.
• Ensure effective interaction with other departments and customer representatives as appropriate.
• Ensure that the manufacturing area is maintained in a clean and orderly manner, including the implementation and enforcement of 5S practices.
• Serve as an organizational change leader that enthusiastically drives organization change, challenges the status quo while communicating the “why” of change.

Required Skills/Abilities:

• A BS or BSc degree with 20 years’ experience in the sciences (chemistry, chemical engineering, or biology) or equivalent education and work history with 10 years of management experience.
• Experience with biopharmaceutical manufacturing processes
• Certification in Process Improvement or Lean/Six Sigma.
• Experience with 24/7 plant operations is strongly recommend.
• CMO experience strongly recommended.
• Strong leadership skills with experience in managing diverse groups/teams.
• Verbal and written communication skills, including ability to pro-actively identify and constructively challenge timeline/demand/capacity misalignments, communicate team progress, identify challenges, and propose solutions both internally and externally.
• Demonstrated ability to effectively develop personnel at many levels.
• Quick learner with the ability to handle multiple tasks simultaneously, maintain focus, and adapt to a variety of challenges.
• Ability to conduct detailed procedures in a time constrained environment.
• Ability to perform capacity and logistics planning.

The annualized salary for this position is $214,600.00 - $243,800.00.