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Manager BASG Drug Product SME


Lake Forest H3, IL
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Job Details

Job Title Manager BASG Drug Product SME

JobID 1612935

Location: Lake Forest H3, IL

Description Role Summary:

The Manager, BASG Drug Product SME, will primarily be responsible for developing and executing sterile Drug Product process scale-up strategies in partnership with PharmSci teams to bring complex products within the CoDev model from the bench (lab) scale to the final commercial scale. The role is also expected to assist the PharmSci team with sound/robust resolutions for complex technical issues encountered during formulation / bench (lab) scale development with respect to impact on the final commercial scale process. The position will also be a sterile Drug Product subject matter expert for Pfizer internal and external sites, and customer representative to selected sites.

Role Responsibilities:

+ Work with R&D in CoDev projects to ensure that new drug products processes are scalable and robust to meet commercial demands

+ Utilize small scale production processes and use scaled down lab processes and equipment to enable process trouble shooting

+ Perform risk assessments, statistical analysis and interpret the results of the analysis

+ Participate in startup efforts of new equipment, software, or processes in manufacturing

+ Process SME for process transfers across the network

+ Serve as a scientific and technical representative for sterile Drug Products process related issues at sites and across the network

+ Responsible for knowing, understanding and acting in accordance with Pfizer's values and our OWNIT culture


BS in Engineering or Science required. Master's degree desirable.

A minimum of 5 years of related experience in process engineering, pharmaceutical industry

Experience in development and or manufacturing of sterile Drug Products complex formulations, e.g. liposomes, nanoparticles

Experience is process development with QbD approach is preferable

Process transfer experience

Familiar with global regulations on drugs, validation/qualification requirements

Excellent communication skills - strong verbal and written skills, ability to work with interdisciplinary and multicultural teams

Ability to focus on specific production processes with great attention to details

Knowledge of sterile injectables - development/scale up, trouble shooting, product transfers, etc.

Physical/Mental Requirements:

Ability to think and work independently and as a team member

Ability to stand or sit as required to monitor manufacturing processes

Non-Standard Work Schedule, Travel or Environment Requirements:

Ability to adjust work schedule to meet business needs - overtime, off shift, weekends, different time zones

Ability to travel to locally and internationally - travel time may be up to 40% according to business need

Organizational Relationships:

This role will interact with multiple functions both internal and external. Primary partners include R&D, other GTS groups and operations.

**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.

**Sunshine Act**

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

**Additional Offer Details:**

+ **Last Date to Apply for Job: 9/20/2017**

+ **Grade: 12**

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 bio-pharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

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