Director, Quality Analytical Development

Apply by eMail:15120205.185@jobfrenzy1.com

Description:
At Wyeth, we have a vision of leading the way to a healthier world. We've committed ourselves to achieving this vision by making quality, integrity and excellence the hallmarks of our business. A Fortune 500 company and global leader in pharmaceuticals, consumer healthcare, and animal healthcare products, we know that our employees are who keep us on the cutting edge of innovative discoveries and superior customer service. To sustain and enhance our leadership position in the pharmaceutical industry, we continue to recruit, develop and motivate individuals whose skills, values, and work ethic will grow and improve our business.

Job Summary
As the Director of the Quality Analytical Development function, you will drive Wyeth Analytical Quality and Regulatory Excellence through the integration of Wyeth Analytical Laboratories with Development and Manufacturing sites to produce robust analytical methodologies and achieve industry leading First Time Quality and Laboratory efficiency from new product transfers through product discontinuation. You will be responsible for leading method development, optimization, validation and transferring analytical methods for new and marketed products, intermediates, and raw materials, evaluation of new instruments and for providing adequate support for pilot plant and other development activities, special projects, investigations and methods involving advanced technology.

Basic Qualifications

You must have at minimum an MS degree in Chemistry, Biochemistry, Biology, Microbiology, Pharmacy or related field, PhD preferred. In addition, you must have at least 10+ years experience in development, analytical sciences, quality control or related areas in the Pharmaceutical Industry with experience in managing teams of scientists. Knowledge of the following areas is critical for success in the role:


Profound understanding of the Technology Development and Transfer process and the associated gate criteria results.


Recognized as Subject Matter Expert in analytical development, knowledgeable on formulations and process development.


Quality by Design principles and their application in product and process development.


Technology and product characteristics of the core brand(s) (drug product and API).


Manufacturing environment and processes and interdepartmental linkages.


Global regulatory environment and process.


Quality Assurance, Quality Control, Analytical Development


Manufacturing, Science and Technology; both for the finished product(s) and as well as the active pharmaceutical ingredient(s) of the core brand(s)/development compound.


Knowledge of applicable cGMPs for product portfolio.


Ideal candidates will have prior experience in most, if not all, of the following and employees developing into this role should develop experience and demonstrated success in the following:


Having managed a site Quality and Compliance laboratory, ideally in more than one site.


Experience in at least two quality and/or science areas.


Working in functions outside Quality and Compliance, e.g. Technology, Validation, Operations, Regulatory; for New Products, experience in Development areas such as Formulations Development, Pharmaceutical Development Centers, and Analytics.


Making sound and effective decisions in a timely fashion that advance the business.


Working with multicultural, cross-functional work teams.


Exposure to Regulatory inspections including interactions with Board of Health representatives and responding to Board of Health observations.


Understanding Global regulatory expectations.


Project Management


ICH Q8, Q9, Q10; Industry Standards


Knowledge of the following areas will be helpful:


Qualified person status or equivalent training


CTD format and global clinical trial and registration processes


Knowledge of Submission Ready Components (SRC)


Relocation may be available for this position.
Wyeth offers competitive compensation and benefits programs, including child-care subsidies, flex-time, business casual attire, educational assistance and professional development programs.
For more information and to apply online, please visit us at: www.wyeth.com/careers
Wyeth is an Equal Opportunity Employer, M/F/D/V.
Search Firm Representatives:
Please Read Carefully.
Wyeth is not seeking assistance or accepting unsolicited resumes from search firms for this employment opportunity. Regardless of past practice, all resumes submitted by search firms to any employee at Wyeth via-email, the Internet or directly to hiring managers at Wyeth in any form without a valid written search agreement in place for that position will be deemed the sole property of Wyeth, and no fee will be paid in the event the candidate is hired by Wyeth as a result of the referral or through other means. Note: Any search agreement entered into with Wyeth prior to January 2004 is hereinafter void.
Search firms are essential to the recruitment and staffing efforts at Wyeth and we value the partnerships we have built with our preferred vendors. For this reason, Wyeth has established and regularly maintains a preferred vendor list. Please note that even preferred vendors need to have a written search agreement signed by the Vice President, Strategic Staffing at Wyeth in place for the specific position in order for a fee to be paid for any candidate referrals.

Requirements:
See Above

Education: Not Specified

Experience: Not Specified

Travel: None

Apply by eMail:15120205.185@jobfrenzy1.com

Job Created: Thu Sep 10 2009 04:27:03 AM
Last Modified: Thu Sep 10 2009 04:27:03 AM