Wednesday, July 29, 2009

Merck and Co. Inc: Associate Director, Durham, NC, US

Merck & Co. Inc., established in 1891, is a global research-driven pharmaceutical company dedicated to putting patients first.

Join us and experience our culture first-hand - one of strong ethics & integrity, diversified experiences and a resounding passion for improving human health. As part of our global team, you'll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.

Part of the Global Vaccine Technology & Engineering (GVTE) organization, Viral Vaccine Technology & Engineering (VVTE) is seeking a highly motivated individual to partner with Operations, Merck Research Laboratories, Quality Operations, Bio-Sterile Validation and the Regulatory groups to meet the targeted manufacturing and compliance initiatives within Viral Vaccine Manufacturing. Viral VTE provides technical support for the manufacture of Merck's cell-culture based vaccines: VARIVAX (Chicken Pox Vaccine), ZOSTAVAX (Shingles vaccine), M-M-RII (Measles, Mumps and Rubella vaccine), VAQTA (Hepatitis A Vaccine) and ROTATEQ (Rotavirus Vaccine).

We are seeking a Technical Subject Matter Expert for vaccines and biologics manufacturing in the area of VALIDATION and FACILITY QUALIFICATION. This person will be responsible for planning and leading execution of the sterilization and cleaning validation activities of a new manufacturing facility being constructed and qualified at the Durham, North Carolina site, as well as supporting the overall process validation efforts. The leader would be responsible for achieving departmental objectives through establishing the validation systems and procedures for the new facility, overseeing the documentation and execution of validation protocols to support facility qualification activities and continuing validation support post-demonstration. This leader would visibly demonstrate commitment to site vision and foster the empowered, team based environment.

Primary activities include, but are not limited to:

1) Develop, Challenge and Execute the validation activities for the facility start-up and technology transfer of a licensed vaccine bulk product to the Durham Site. Maintain a close liaison function with Operations, Technical Operations, Quality and Bio-Sterile Validation to ensure global alignment on validation strategy.

2) Develops objectives, policies, and site programs relating to the validation activities for the new bulk vaccine facility at the Durham, North Carolina site. Supports all quality and safety initiatives.

3) Oversee validation activities for the Durham bulk facility to ensure that quality standards are achieved and that timing for qualification activities are met.

4) Partner closely with the process validation/tech transfer leader to ensure validation readiness to support salable production, license preparation and pre-approval inspection activities.

5) Responsible for building/growing the Organization's functional excellence in the validation arena. Recruits and directs the engineers/scientists necessary to perform the site validation roles supporting bulk manufacturing at Durham, through mentoring, assignment selection and training.

6) In the longer term, provides validation support, troubleshooting, and atypical resolution to ensure a consistent and reliable supply of vaccines and sterile products. Accountable for providing review/support for regulatory filings, process Descriptions, atypical process reports and change requests.

7) Maintains functional excellence through internal and external relationships within industry, academia, and professional/technical organizations.

8) Assists in the preparation and operates within the approved GVTE Profit Plan.

·BS in Chemical, Biochemical, or Biomedical Engineering or Chemistry, Biology, Biochemistry, or Molecular Biology, or other Life or Health Science field.
· 10 years post-bachelors degree experience in validation, biologics manufacturing or biologics technical support.
· Previous people management experience
· Strong collaboration and teamwork skills
Specific validation experience totaling 5 or more years in at least one of the following areas is required:
· Steam sterilization, including both SIP (sterilize in place) systems and autoclaves.
· Cleaning Validation, including both CIP (clean in place) and COP (clean out of place) systems.

· Experience preparing regulatory submissions and managing interactions during regulatory inspections.
· Experience with matrix organizations preferred. Strong knowledge of GMPs and Quality Assurance.
· Previous experience with new facility construction and startup/qualification activities
· Process validation of bulk biological production processes; specifically 5 years of validation experience involving biologic products or reagents.
· Validation experience in the launch of a new facility or product, specifically involvement in a PAI (prior approval inspection)
· Experience in developing validation procedures and systems for a site or facility

Consistently cited as a great place to work, we discover, develop, manufacture and market a wide range of vaccines and medicines to address unmet medical needs. Each of our employees is joined by an extraordinary sense of purpose - bringing Merck's finest achievements to people around the world .

We offer an excellent salary and an industry-ranked benefits program, including tuition reimbursement, work-life balance initiatives and developmental programs at all levels. Merck's retirement package includes a pension plan and one of the best 401(k) plans in the nation. to create a profile and your resume for requisition # ENG002080.

Merck is an equal opportunity employer, M/F/D/V - proudly embracing diversity in all of its manifestations.

Our work is someone's hope. Join us.
Where patients come first - Merck
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Merck is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Merck via-email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.

Primary Location: US-NC-Durham-RTP

Nearest Major Market: Durham
Nearest Secondary Market: Raleigh
Job Segments: Management, Manager

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