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Director, Site Engineering Direct Hire CA
Job ID: 15459 Direct Hire CA
Director, Site Engineering
The Director of Site Engineering will lead and manage the LA’s site engineering team (over 100 FTE's). The position reports into the Head of Engineering (based remotely). Provides engineering and maintenance support to the site to achieve capacity plans and fulfillment targets. Maintains equipment and facilities, performs facilities management including operations of utilities and critical systems, and provides engineering technical support, and capital planning and execution. Serves as a member of the Engineering Leadership Team. Serves as a standing member of the Site Leadership Team, which helps set strategic direction for all site engineering organizations including validation and is accountable for operating results.
- Frequently manages an organization and a budget in excess of $5 million dollars. Based on significant technical expertise, reviews and approves complex design concepts of technical staff.
- Provide strong technical direction to staff.
- Maintenance and Facilities Engineering Services of utilities, facilities, production equipment and clean media systems across the Los Angeles site
- Build/execute financial plans and budgets, and allocating resources effectively and efficiently to meet business goals
- Develop/implement strategic plans to provide reliable plant utility and production equipment services to accomplish the vision to result in a “competitive advantage” for the company
- Drive continuous improvement in operations and a process oriented, fact based culture
- Develop process understanding and control to support production of high-quality products with minimal waste, and assure that processes and products are safe and effective.
- Manage operations of internal and external (oversight) of workforces executing maintenance, metrology/calibration, and facilities services at cGMP biotech sites with 24/7 operations (if needed)
- Manage Central reliability engineering of all Maintenance and calibration activities
- Manage safety, compliance, and financial performance of organization while meeting customer KPIs and production goals
- Assure that Reliability Maintenance, and sound maintenance industry practices, cGMPs, SOPs, Division Procedures, Engineering Standards and Good Engineering Practices are appropriately integrated in all maintenance processes.
- Present proposals to senior management for consideration and allocation of funds. Responsible for preparation of project cost estimates up to multi-million-dollar range.
- Directs all project expenditures and cost tracking.
- BS degree in Engineering and over 10 + years of relevant industry experience.
- Must have proven track record of manage large teams (60+ FTEs) and large operating budgets ($30Million +)
- Pharmaceutical experience required.
- Must have experience working in large, onsite cGMP Manufacturing environments for Pharma products (preferably biologics or Plasma)
- Must be able to work in controlled environments requiring special gowning.
***Relocation available for qualified candidates. Must be eligible to work for any US Employer for an indefinite amount of time.
Director, External Manufacturing Direct Hire MA
Job ID: 15421 Direct Hire MA
Growing, Mid-Size company north of the city here in MA looking to add a Director, External Manufacturing to their team! Director will lead Commercial and Clinical manufacturing efforts across their CMO manufacturing Platforms (small molecule). They will lead a cross functional team to ensure supply continuity by leading implementation of Continuous improvement opportunities, Implementation of best practices as well as oversight of day-today manufacturing through our Drug Substance and Drug Product Supply Chain. Director will be responsible for the implementation of new and existing processes, support new site selection and supply assurance for our existing and pipeline programs. The candidate will partner closely with Technical Operations and Quality to ensure alignment with best practices as well as corporate objectives. This position is both strategic and operational with a focus on embedding a culture of continuous improvement and innovation across Technical Operations. Other responsibilities include but not limited to:
- Lead Tech Transfers and New Initiatives
- Oversight Operations
- Lead for continuous improvement programs
- Manage Process Investigations, Failures
- Lead Change management
- Lead CMC Management for clinical and commercial operations
- Collaborate with Quality and Supply Chain to support ongoing manufacturing performance
- Supporting Type 2-4 Investigations, OOS, OOT’s and Process Performance Initiatives
- Support Process Modeling, Sensitivity Analysis and Control Strat for Clinical and Commercial Products to identify and help prioritize lifecycle opportunities
- Support Development Efforts to improve process performance and efficiencies.
- Support regulatory filings (IND, NDA’s, annual updates)
- BS/MS or Ph.D. degree in relevant field AND 10-15 years Commercial Manufacturing experience.
- Experience through 3rd party management is essential (CMO's, etc.)
- Subject matter expertise, highly effective interpersonal leadership skills, and a high degree of passion will be required to be successful. Process Engineer, Chemical Engineer
- Strong process engineering and scale-up experience preferred
- Strong Hands on experience in manufacturing operations, ideally in small molecule synthesis preferred.
- Process Engineering experience to Lead development projects both internally and through our external collaboration
- Ideal candidate will be highly organized with key competencies in manufacturing, CMC and Manufacturing operations in Drug Substance as well as Drug Product