Who we are
The opportunity
We are looking for an experience cell culture Manufacturing Associate, to support Upstream Manufacturing activities.
How you’ll spend your day
All areas of responsibility listed below are essential to the satisfactory performance of this position by any incumbents with reasonable accommodation if necessary. Any non-essential functions are assumed to be included in other related duties or assignments.
- On-the-floor lead for cell culture and bioreactor operations. Primarily focused on cell culture activities; with a secondary focus on small scale inoculum preparation.
- Operates and maintains production equipment as it relates to cell culture – including analytical instrumentation to support cell culture activities and in-process testing.
- Leads or performs a variety of complex tasks under general guidance and in accordance with cGMP’s.
- Responsible for drafting of batch records and SOPs, executing, documenting and reviewing data, and review and approval of manufacturing documents according to cGMP guidelines.
- Maintain records to comply with regulatory requirements.
- Initiates deviations, assesses product quality impact, and proposes, owns and executes Corrective and Preventative Actions (CAPA).
- Change owner for implementation or revision of equipment, documentation, and material specifications.
- Maintains daily work schedule and relevant resource requirements.
- Takes the lead on the floor with planning of activities and provides guidance to junior staff on execution
- Proposes implementation of improvements to optimize manufacturing processes. Monitor processes and results and suggest methods to ensure process success.
- Develops effective working relationships with both internal and external partners.
- Provides training to new personnel as needed.
- Assists in audits from internal or external partners.
- Transparent and adheres to quality standards set by regulations and cGMP policies, procedures and mission.
- Communicates effectively with managers, colleagues and subordinates.
- Ability to lead effectively as a team player in all aspects of cGMP- compliant production activities.
Your experience and qualifications
Any equivalent combination of education, training and/or experience that fulfills the requirements of the position will be considered.
Qualifications/Skills Required:
- BS degree in Chemical Engineering, Biotechnology, Biology, Chemistry or related Engineering discipline with 2-4 years mammalian cell culture experience.
- MS with at least 1 years’ experience in upstream mammalian cell culture and cGMP manufacturing with 1 to 3 years as a team lead or supervisor.
- Knowledge of cell culture process steps including cell banking, thaw and expansion, production, and harvest.
- Experienced with manufacturing of drug substance following SOPs and batch records within a cGMP regulated environment.
- Knowledge of specific product-related operations in cell culture/fermentation.
- Skilled in leading upstream production in absence of management.
- Ability to ensure that plans and resources (people, facilities, supplies etc.) are efficiently utilized to ensure uninterrupted supply of products produced.
- Ability to mentor and train colleagues.
- Occasional off shift work and regular weekend work will be required.
- 1st shift and/or possible swing shift, if necessary to meet manufacturing process schedule.
- On-call required for acknowledging alarms from equipment during off shift hours.
Enjoy a more rewarding choice
We offer a competitive benefits package including Medical, Dental, Vision, and Prescription coverage starting on the first day. We also offer Disability and Life Insurance, Paid Time Off, 6% match on the 401(k), Employee Stock Purchase Plan and Tuition Assistance.
Already Working @TEVA?
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Teva’s Equal Employment Opportunity Commitment
Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.
Important notice to Employment Agencies - Please Read Carefully
Teva Pharmaceuticals USA does not accept unsolicited assistance from agencies for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
This position is not eligible for sponsorship. To be considered for this opportunity, you must apply on our career page.