Company: Germer International
Posted on: May 24, 2023
Director of Production
A member of the Site Leadership Team, the Director of Production is
responsible for the compounding, filling, and packaging of the drug
onsite. This role will work cross-functionally with Quality,
Engineering, Supply Chain, HR, Operational Excellence and Finance.
The incumbent will be responsible for building strong working
relationships across the site and driving employee engagement to
next level and ultimately delivering safe and effective products to
patients. The role is also responsible for building both a high
performing team and high performing systems to drive and sustain
- Direct drug production and packaging groups to ensure the
timely delivery of manufacturing batches and successful
implementation of new technology.
- Lead the Operational Readiness workstream for the transfer of
the drug fill / finish to the company site.
- Assist the VP, US TechOps with establishing strategic direction
for the drug manufacturing resources and activities and setting
objectives to maximize the value of the organization's
contributions by adapting new technologies, capabilities and
providing educational opportunities for team members.
- Maintain the operational facility in the highest level of cGMP
compliance per FDA or other health authorities,
- Cross functional collaboration with Validation, Quality
Assurance, groups to plan and implement the execution of cGMP
activities in manufacturing operations for commercial
- Ensure continued operational efficiencies are realized with
reliable schedule adherence, and on time delivery of product, while
maintaining the ability to react to changing customer
- Share responsibility for short- and long-term resources and
facility planning, and perform managerial duties as required, e.g.
budgets, personnel performance appraisals, training, etc.
- Monitor and report progress of projects within agreed upon
timelines, ensuring Company objectives are met.
- Responsible for participating and representing the drug
manufacturing operations in audits as appropriate.
- Develop and lead a culture of learning, respect, and employee
growth. Establish the department's strategic vision and mentor the
manufacturing ops team towards goal achievement.
- Requires minimum Bachelor's degree in an Engineering or
- 10+ years' relevant experience with 5 years of production
- Experience working in Aseptic manufacturing; Good understanding
- Experienced in Manufacturing operations, tech transfer &
validation, product formulation, process-technology and engineering
- Experience in deviation and technical investigations and
managing teams of > 20 is required
- Outstanding interpersonal skills; ability to build strong
relationships with cross-functional team members and lead through
- Able to work under pressure and meet deadlines
- Excellent verbal and written communication skills; strong
presentation skills as this role requires the ability to
communicate and connect with all levels of the
- Strong follow-up skills and attention to detail.
- Knowledge of Microsoft Word, Excel, Power Point, and
- Experience in a lean manufacturing environment
Keywords: Germer International, Newark , Director, Production, Professions , Morristown, New Jersey
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