Senior Associate / Manager Clinical Supply Packaging Job in Andover, Massachusetts US

Senior Associate / Manager Clinical Supply Packaging

Org Marketing Statement Pfizer Inc: Working together for a healthier world Founded in 1849, Pfizer is the world's premier biopharmaceutical company taking new approaches to better health. We discover, develop, manufacture and deliver quality, safe and effective prescription medicines to treat and help prevent disease for both people and animals. We also partner with healthcare providers, governments and local communities around the world to expand access to our medicines and to provide better quality health care and health system support. At Pfizer, colleagues in more than 90 countries work every day to help people stay happier and healthier longer and to reduce the human and economic burden of disease worldwide. Job Focus The position is responsible for transferring key technical drug product process and manufacturing information into Pfizer internal clinical and commercial manufacturing sites as well as external vendors when needed. This position involves adherence to GMP technology transfer and manufacturing guidelines. Through strengths in technology, validation, and teamwork, successful individual will help Pfizer meet critical project challenges and key business milestones. The knowledge and experience gained within this group helps maintain compliance and build quality into the process. Qualifications EDUCATIONAL BACKGROUND: B.S. or B.A. in a scientific major is a minimum with a desired B.S. or B.A.in chemical engineering. Experience in equipment, systems, and process validation in biotech drug product arenas. WORK EXPERIENCE/SKILLS: 5-10 years of relevant technical, manufacturing, and validation experience in a GMP environment. The position requires a person with a very strong technical background and experience with aseptic drug product manufacturing that can work independently. This is an important position where technology transfer to clinical manufacturing areas as well as first time transfers to commercial manufacturing sites is a primary responsibility. An emphasis is placed on the ability to coordinate and to interface with technical colleagues from cross-site functional areas with a high energy to motivate groups of people to accomplish project goals. Experience should include equipment and process validation, and technical troubleshooting in manufacturing environments. Excellent technical writing skills with technical protocols and reports are a requirement. It is also expected that this person will be a manufacturing and process validation technical writer for the Chemistry, Manufacturing, and Controls section of clinical and commercial submissions to regulatory agencies. Travel is an important part of this job as the individual takes on and supports drug products getting closer to commercialization. The Pharm RD group is responsible for transferring newly developed drug products to commercial manufacturing sites. The amount of travel varies, but the responsibility of being on site for engineering or conformance runs is expected, but depends on the level of oversight needed. Coordination of technical reports within the technology transfer process as a technology leader is expected. Responsibilities will include supporting technical manufacturing process or strategy discussions with regulatory agencies through telecons or on site inspections. The ability to communicate effectively with international and domestic contract manufacturers and internal Pfizer sites is necessary. To achieve our shared goals, the candidate must be willing and able to work with others through formal and informal collaboration across the organization, share information and bring the right people together who are critical to accomplishing results. Input must sometimes be solicited from others who may be outside the normal work sphere but have pertinent knowledge or expertise. The candidate will be responsible for building consensus to reach goals that all can support, while moving forward with acceptable results. It will be expected to comply with site SOPs and GMP requirements in our Pfizer facilities as well as contract manufacturer site documentation. Equal Employment Opportunity 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 employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Pfizer in the U.S. In certain circumstances it may be advantageous to Pfizer to support the application(s) for temporary visa classification and/or sponsor applications for permanent residence so that a foreign national colleague can accept or remain in a work assignment in the U. S. For certain classes of temporary visas, the resulting work authorization may be specific to Pfizer and the specific job and/or work site. Pfizer may at its business discretion decide to or refrain from obtaining, maintaining and/or extending the temporary visa status and/or sponsoring a colleague for permanent residency and /or employment eligibility, considering factors such as availability of qualified U.S. workers and the colleague's long-term prospects for securing lawful permanent residence, among other reasons. Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work for Pfizer in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Pfizer's support of a colleague's temporary visa application or sponsorship of a colleague for permanent residence be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the colleague and Pfizer. *This job post was placed on PharmaDiversity Job Board with permission of this employer. If viewing this post anywhere else, the "apply" click should lead you to PharmaDiversity Job Board for authentic job post view with direct employer application. For application attention if web source is requested please use "PharmaDiversity" or "PharmaDiversity Job Board". Pfizer prefers that you apply to this job directly on their site