A career with MilliporeSigma is an ongoing journey of discovery: our 52,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. MilliporeSigma is a business of Merck KGaA, Darmstadt, Germany.
The Fill/Finish Team Lead will be the primary point of contact for all assigned operations within the scope of client specific fill and finish processes. He/She will be expected to attend all relevant project meetings as assigned and coordinate with Master Scheduling, Project Management, and Quality to effectively and efficiently execute the manufacturing plan under the Carlsbad site “Right the First Time” policy and clients’ expectations.
The Team Lead will demonstrate a high level of competency and knowhow related to all aspects of technical cGMP biopharmaceutical aseptic fill operations (both manual semi-automated and automated.) The Team Lead will be a hands-on resource ensuring production projects are efficient, accurate, compliant, and the associated operators have the skill levels that match the related work. The Team lead is expected to conduct themselves with honor and integrity as demanded by the nature of cGMP clinical and commercial production of vaccines and biologic therapeutics intended for human use.
In addition, this position is responsible for leading the assigned manufacturing staff working in the facility to meet corporate production goals, as well as influencing related, cross-functional groups to meet these objectives.
- Ensure that the manufacturing fill finish operation is compliant to all applicable cGMP regulations.
- Maintain operations within contracted guidelines in order to successfully produce high quality bulk and finished products.
- Build and maintain a staff that is both technically qualified and well trained in cGMP manufacturing, while providing a motivating environment and opportunities for their professional advancement in a safety conscious environment.
- Define, implement and optimize the manufacturing schedules.
- Ensure consistent product quality through appropriate manufacturing programs and by working with other groups such as Quality Control and Quality Assurance.
- Lead process trouble-shooting efforts.
- Develop, implement and update all production SOPs, Batch Records and other documentation needed for GMP production projects.
- Ensure that deviation reports are written accurately and appropriately as they occur. Track and implement corrective actions.
- Provide a safe working environment for employees.
- Evaluate employee efficiency and productivity.
- Customarily and regularly exercise discretion and independent judgment in the performance of the duties described above.
- Spend 50% or more of time on work directly and closely related to carrying out exempt functions.
Who You Are
- Education: Bachelor of Science degree in a science related field.
- At least 8 years of directly related experience
- At least 4 years of leadership experience in a GMP environment
- Supervisory experience is preferred
- Essential and Critical Skills:
- Well versed in aseptic manufacturing processes
- Excellent written and verbal communication skills
- Well-honed priority and time management skills
- Knowledge of relevant unit operations.
- Bulk Drug Formulation and sterile Filtration
- Sterile Fill / Finish
- Working knowledge of desktop computers and technical equipment
- Lean Six Sigma methodologies
ADDITIONAL LOCAL NEEDS
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is occasionally exposed to work near moving mechanical parts; fumes or airborne particles; toxic or caustic chemicals; risk of electrical shock and vibration. The noise level in the work environment is usually moderate.
The employee may frequently be required to sit and talk or hear. The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl and taste or smell. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities by this job include close vision, depth perception and ability to adjust focus.
The employee must be able to work off-shifts, weekends, and additional hours as required.
The employee must have the ability to perform moderately physical activity.
The employee must have the ability to perform very complex tasks with attention to detail.
The employee must be self-motivated, work well in a group, and communicate well with all levels of the operations team.
What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!
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The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to his/her Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because he/she made a good faith report of discrimination.