Senior Manager Gene and Cell Therapy - Durham, NC | Biospace
Get Our FREE Industry eNewsletter

Senior Manager Gene and Cell Therapy

Pfizer Inc.

Apply
Location:
Durham, NC
Posted Date:
1/20/2017
Position Type:
Full time
Job Code:
66844.22045
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

About Pfizer

A career at Pfizer offers opportunity, ownership and impact. All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.



Role Description

The qualified candidate will join the PharmSci Quality organization to enable delivery of biological therapeutics in Chapel Hill, NC. We are building capabilities to lead the industry and seek experienced candidates to advance novel products to the market through innovation, development and execution of quality management systems to support these technologies. The qualified candidate has responsible for setting and implementing strategy with the Site leader for the Chapel Hill Quality Operations including responsibility for day to day contributions for the External Operations and Portfolio support team. This position includes instilling and influencing a strong quality culture at the site and globally. This position requires solid understanding of compliance regulations, process validation, and knowledge of quality by design concepts and quality systems as they relate to manufacturing, testing, stability, scale-up and development of fermentation and purification processes for the production of Gene therapies, Human Biotherapeutics and vaccines.



Responsibilities

* The qualified candidate may lead a group of 2- 4 colleagues who contribute to the delivery of Gene Therapy, Biological and Vaccine assets
* Leverages and set expectation for goal setting, ongoing assessment and coaching and performance evaluation to motivate direct and indirect reports and deliver results for department or business line.
* Provide quality oversight for operational activities including disposition of CTM (i.e. biological drug substance, vaccines, device, drug product, analytical and material supporting drug safety studies).
* Lead complex investigations, and deviations including assuring root- cause analysis is complete and accurate. Support Notification to Management process and AQRT.
* Provide quality oversight for operational activities including disposition of CTM (i.e. biological drug substance, vaccines, device, drug product, analytical and material supporting drug safety studies).
* Lead and support initiatives that contribute to strengthening quality culture from a global and site perspective.
* Collaborate between sites where improvements have synergistic opportunities or where there are requirements for consistency or collaboration.
* Lead and/or participate in PSQA or cross-functional limited duration teams where impact can be global in nature (i.e. specialty councils, leading network teams).

Requirements

Qualifications

* BA 10 plus years or MS 5-7 years Scientific discipline or related field. Immunology or Biologics/Vaccines experience preferred.
* Team leadership experience with demonstrated ability to operate with agility in a highly diverse and complex environment.
* Experience with bio-pharmaceutical drug substance/product manufacturing processes and parenteral dosage forms.
* In depth knowledge of cGMP regulations as applied to Biological DS/DP manufacturing, and related quality systems.
* Must possess strong written and oral communication skills as well as strong computer skills.
* Must have the abilities to manage work independently, pay attention to detail, exhibit strong interpersonal skills, and the ability to work effectively in teams.
* Experience in troubleshooting operational issues that can occur during manufacturing/testing and assessing their impact to product quality.
* Well versed in quality investigation techniques and reporting systems.
* Working knowledge of EU cGMP& US regulations.



EEO & Employment Eligibility

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.