MSAT Manager (Device& Packaging Development)
- Regeneron Pharmaceuticals, Inc.
- Troy, New York
- Start date
- Mar 23, 2023
- Information Technology, Project/Program Management, Manufacturing & Production, Manufacturing/Mechanical
- Required Education
- Bachelors Degree
- Position Type
- Pharm Country, Best Places to Work
Regeneron is currently looking for a Manager to join our Drug Product (DP) Manufacturing Sciences and Technology (MSAT) Device Assembly, Labeling and Packaging team. The Manager DP MSAT leads a team responsible for supporting the broader device assembly, labeling and packaging development activities focused on transfer and establishment of robust finished drug product processes, supporting external and internal manufacturing operations globally. The team is responsible for supporting the development and management of the technical documentation associated with labeled drug products for new product commercialization and life cycle change management of established commercial products. The technical documentation includes labeling component technical drawings specifications and Bills of Materials (BoMs). The position is also responsible for ensuring site to site consistency of printed packaging components during new commercial process establishment after the processes are successfully implemented as necessary, reviews process data and supports investigations related to labeling artwork, package component specification development processes and package component manufacturing and supply.
As a Manager DP MSAT , a typical day might include the following:
- Leads an engineering team to develop artwork file technical structures, package component specifications and BoMs necessary for new product introduction and life cycle management.
- Oversees activities in assigned area of expertise, which may include incoming inspection of components, assembled device and product labeling and secondary finished packaging.
- Partners with cross-functional internal and external teams to ensure successful process transfers.
- Reviews and/or approves manufacturing documentation associated with transferred processes. Reviews process data to ensure operational robustness and consistency.
- Support of component supply management and establishment of new or alternate component supply sources.
- Manages investigations related to assigned area to identify a root cause(s) and to identify and implement effective corrective and preventive actions.
- Develops organizational standards and systems for processes to meet growing product portfolio.
- Establishes standard procedures for process development activities and integrates those with other Regeneron business and quality systems.
- Authors technical reports and protocols in support of cGMP activities.
- Tracks and reports project milestones.
- Establishes an internal and external network to stay abreast of current regulatory environment and industry standards.
- Collaborates with internal and external teams to seek out opportunities to improve process performance and cGMP operations.
- Supports innovation mindset within organization and encourages development of novel ideas.
- Responsible for leading, coaching and developing direct reports.
- Maintains required training status on Regeneron specific work instructions and SOPs.
- Travels to contract manufacturers or business partners, as required, approximately 10-%.
This role might be for you if:
- Experience interacting with Contract Manufacturing Organizations.
- Demonstrated technical expertise in finished drug product artwork development , package component specification and technical drawing development and management.
- Knowledge of labeling and package component manufacturing.
- Knowledge of industry practices and regulations (cGMP, Annex I) and across multiple health authorities (e.g. FDA, EMA, MHRA, etc.).
- Strong project management, interpersonal, cross-cultural, communication, negotiation and problem-solving skills, qualification preferred.
To be considered for the Manager DP MSAT you must have a BS/BA in a scientific, engineering or related field. For various levels you must have the following:
DP MSAT Manager: BS/BA in a scientific, engineering or related field and 7+ years of related experience in a pharmaceutical/biologics cGMP environment or equivalent combination of education and experience.
Sr. DP MSAT Manager: BS/BA in a scientific, engineering or related field and 8+ years of related experience in a pharmaceutical/biologics cGMP environment or equivalent combination of education and experience.
#HyrbidDoes this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible employees at all levels!Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.
Salary Range (annually)$101,800.00 - $194,200.00
Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to seven FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye disease, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, infectious diseases, pain and rare diseases.
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune® which produces optimized fully-human antibodies, and ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.
Stock Symbol: REGN
Stock Exchange: NASDAQ
- Regeneron Pharmaceuticals, Inc.
777 Old Saw Mill River Road
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