External Manufacturing Specialist

Rensselaer, NY, United States
Jul 09, 2019
Required Education
Bachelors Degree
Position Type
Full time
Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.

Summary: Collaborates with Drug Product Manufacturing Team to ensure business objectives are met through effective support of external manufacturing activities; organizes and executes critical external manufacturing requirements to ensure world-class performance of IOPS (Industrial Operations & Product Supply) product supply chains.

Essential Duties and Responsibilities include, but are not limited to, the following:

• Reporting to a Strategic Relations Lead, support the DPMT in all activities necessary to manufacture, test, release and deliver Regeneron medicines to patients on time and in full

• Partner with management to lead RFP (request of proposal) and budgeting activities for CMOs (contract manufacturing organizations)

• Oversee and execute shipping documentation requirements to and from CMOs

• Maintain, update and provide status of external manufacturing activities via schedules and checklists

• Review CMO records and support investigations if needed in accordance with Regeneron requirements

• Track, trend and monitor external manufacturing data; prepare reports analyzing data and making recommendations proactively with minimal supervision

• Drive continuous improvement of external manufacturing systems and processes

• At least 25% of travel to CMOs is required

Knowledge, skills, and abilities:

• Strong interpersonal, written and oral communication skills

• Fluent in English with a preference given to candidates with competencies in German and/or French (oral and written)

• Basic knowledge of regulatory compliance inclusive of cGMP, FDA regulations, familiarity with ICH guidelines and EU regulations

• Proficient in Excel, PowerPoint, Visio, Word, etc. in addition to experience working within shared work environments

• Experience with documentation and quality systems

• Prior knowledge in Advanced Planning systems is desired

• Exhibits a degree of ingenuity, creativity and resourcefulness in evolving and ambiguous environments

• Shows resiliency and flexibility in the face of challenges and adversarial situations

• Experience in collaborating with CMOs/CRO

Education and experience:

• Associate Specialist; minimum of BS/BA in scientific discipline with 0-2 years of related experience in cGMP manufacturing operations (clinical and/or commercial drug products).

• Specialist; minimum of BS/BA in scientific discipline with 2+ years of related experience in cGMP manufacturing operations (clinical and/or commercial drug products).

• Senior Specialist; minimum of BS/BA in scientific discipline with 5+ years of related experience in cGMP manufacturing operations (clinical and/or commercial drug products).

This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.

To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.