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Production Manager

Kelly Services


Location:
Bedford, MA 01730
Date:
07/16/2018
2018-07-162018-09-15
Kelly Services
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Job Details

**Manager, Production**



**Overview**



Responsible for supervising clinical and commercial manufacturing operations. Ensure production operations are conducted in accordance with regulatory and cGMP compliance, while delivering to the production plan of record. Instill a culture of continuous improvement within production operations, and foster team growth environment. Collaborate with Regulatory/Quality, Facilities, and Development with regards to project plans and the successful production execution of late phase clinical, new product launch and sustainable commercial manufacturing activities.



**Responsibilities**




+ Establish plans and deliver on the established Production Operations annual goals and objectives.

+ Define necessary corrective and preventative action in response to internal, regulatory, and customer audit requirements as well as deviation investigation.

+ Instill a culture of continuous process improvement with a quality focus. Pursue industry best practices associated with clinical and commercial production operations.

+ Manage daily production operations in late phase clinical, new product launch and commercial manufacturing.

+ Review Master Batch Records, SOPs, Qualification/Validation protocols and reports, and other essential cGMP documents.

+ Write and revise Standard Operating Procedures and other operational documents as needed.

+ Work with counterparts in Quality Assurance and Quality Control to release material in a timely fashion.

+ Provide appropriate coaching, development, and associated performance management for the production operations staff.

+ Perform other duties as required.



**Qualifications**




+ Bachelors Degree in Scientific, Engineering or related discipline

+ 10 years of experience in pharmaceutical drug product manufacturing with specific responsibilities in supervision and new product introduction

+ In-depth knowledge of cGMPs and working in a regulated environment

+ Experience writing and developing SOPs and other regulatory documentation

+ Proficiency in Microsoft Office Applications

+ Excellent organization, communication and analytical skills are required

+ Mobility and ability to lift up to 50 lbs.

+ Must be able to work in a cleanroom environment **.**






**Why Kelly** **** **?**



With Kelly, youll have access to some of the worlds highest-regarded scientific organizations
providing you with opportunities to work on todays most challenging, research-intensive, and relevant
projects. Our connections can lead you to innovative scientific pursuits youll be proud to help
advance. We work with 95 of the Fortune 100 companies, and found opportunities for more than 9,000
scientific professionals last year.


You pursued a career in science to fuel your quest for knowledge and your desire to make the world
a better place. Let Kelly fuel your careerconnect with us today.




**AboutKelly Services** ****



As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit kellyservices.com and connect
with us on Facebook , LinkedIn and Twitter .


Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females,
Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is
committed to employing a diverse workforce. Equal Employment Opportunity
is The Law.
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