Manufacturing Associate I
Astellas

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!



Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com.



Astellas Institute of Regenerative Medicine (AIRM) is a wholly-owned subsidiary of Astellas Pharma Inc and focused on the development and commercialization of stem cell and regenerative medicine therapies. Astellas is an R&D-driven global pharmaceutical company whose philosophy is to contribute to the improvement of people's heath around the world through the provision of innovative and reliable pharmaceutical products.



AIRM has a world-class R&D team, and is pursuing a diverse range of disease indications, ranging from macular degeneration (currently in clinical trials) and other ocular indications to vascular and autoimmune disease. AIRM's intellectual property portfolio includes pluripotent stem cell platforms -- both embryonic and induced pluripotent stem cells as well as other cell-based therapy research programs. AIRM is headquartered in Massachusetts.



Astellas is announcing a Manufacturing Associate II opportunity at their Astellas Institute of Regenerative Medicine (AIRM) site in Westborough, MA.



Purpose:

In strict compliance with cGMP regulations, the Manufacturing Associate II in the Cell Manufacturing group executes all routine operations in the production of a biological product. The position performs duties under supervision and according to standard operating procedures. The candidate should be a highly motivated self-starter who has ability to work in highly regulated cGMP environment.



Essential Job Responsibilities:


* Executes cGMP manufacturing operations following Standard Operating Procedures (SOPs), Batch Records and forms.
* Able to perform aseptic technique in a biological safety cabinet including but not limited to media preparation and changes, cell passaging and in-process testing.
* Completes required documentation following proper GMP recording of entries and comments in batch records, forms and protocols.
* Initiate Document Change Requests; author, revise and review manufacturing documentation.
* Operate and ensures proper maintenance of BSC's, microscopes, incubators, centrifuges, pH meters, and other manufacturing equipment including CO2 and Liquid Nitrogen tanks and systems.
* Works within the team and department in order to follow best practices and meet department goals.
* Reports any issues related to manufacturing performance, process and safety to management in order to ensure safety, compliance with regulations and cGMPs and to facilitate continuous process improvement.
* Perform visual inspection of the final drug product vials.
* Complete the required qualification for the visual inspection program.



Organizational Context:


* Reports to the Manager/Supervisor of Cell Manufacturing





Qualifications:

Required:


* High School Diploma with 5-7 years of strong relevant experience on in vitro Mammalian cell culture; Associate Degree with 4-6 years, BA/BS degree with 3+ years, MS with 0-2 years of related experience.
* Production/Processing - Knowledge of raw materials, production processes, quality control, and other techniques for maximizing the effective manufacture of pharmaceutical products. Includes advanced knowledge of aseptic technique and basic lab instruments, (Centrifuge, Microscrope, CO2 Incubator, Pumps, Scales, etc.).
* Biology - Knowledge of Cell Biology.
* Safety/Security - Knowledge of relevant equipment, policies and procedures to promote effective and safe operations for the protection of people, data and company property.
* Weekend and Holiday work as required.



Preferred:


* Experience with handling Incidents and Deviations
* Experience with Human Embryonic Stem Cells (hESCs) or Induced Pluripotent Cells (iPSC) and their derivatives.


Benefits:


* Medical, Dental and Vision Insurance
* Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down
* 401(k) match and annual company contribution
* Company paid life insurance
* Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
* Long Term Incentive Plan for eligible positions
* Referral bonus program



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