Contract Manager/Sr Manager

Job Description & Duties: Reside full time in a European Drug Product Contract Manufacturing Site as the only Wyeth representative in a non-Wyeth organization. Oversee production operations of Wyeth products to assure proper controls are in place to assure process consistency and product quality. Manage relationship with the contract manufacturing site(s) ("Sites"). The objective is to assure a productive and effective relationship resulting in effective and responsive communications, efficient operations, and optimum cycle times for the Site and Wyeth as it relates to our drug products.

Operations:
Oversee all manufacturing activities for Wyeth products at the contractor site. Includes active monitoring of production operations as well as review of critical documentation.
Coordinate and support batch record review and product disposition activities.
?Ensure successful and timely manufacturing operations for the product(s) and/or site(s) assigned.
?Manage open production issues that impact the project/process. Take the lead role in assessing and resolving Contractor process deviations. Completes CAPA's, DIR's and investigations relative to production issues.
?Manage change control.
?Manage the review/approval process for contractor documents within Wyeth BioPharma.
?Coordinate, support, and manage the Business/Quarterly Meetings. Establish, implement, and effect Joint Service Procedures.

Management of Assigned Projects:
This requires, but is not limited to a clear understanding, communication, and agreement of the project/product requirements and deliverables.
?Tracking and managing of all tasks, completion dates, and Wyeth project team members
?Tracking and follow-up of all key production related activities.
?Support product and process technology transfer to Contract sites, along with completion of associated qualification, validation, and certification activities. Assist in specifying and qualifying, and responsible for ordering, new product/process equipment for Contract sites.
?Support product and packaging technical transfer, qualification, and validation activities at contract sites.
?Ensure that all of the details are addressed in preparation for product launches (SOPs, Qualifications, MBRs, setting-up systems, and coordinating activities between the Wyeth sites and CMs).
?Author protocols, reports, SOP's, Technical Transfer Documents and specifications, as appropriate.
?Responsible for DPMO Section of Annual Product Reviews.
?Assists with formal audits of Contract sites as part of the audit team.
?Travel (approx. 10 - 25%) is required.

Requirements:
BS degree in a Life Science discipline or equivalent experience.
Quality Assurance/Quality Control background is a plus.
Strong analytical and computer skills (Windows, MS Word, Excel, Project).
A minimum of 10 years experience in a drug product manufacturing environment, preferably aseptic fill/finish and lyophilization.
Excellent communication, organizational, and interpersonal skills are required



Wyeth offers competitive compensation and benefits programs including stock
options, child-care subsidies, flex-time, business casual attire,
educational assistance and professional development programs. Please
forward your resume with salary requirements and job reference code to the
address below.

For more information, visit our website at