Regeneron
Regeneron is currently looking for an Associate Drug Product (DP) MSAT (Manufacturing Sciences and Technology) Engineer to join our Process Sciences Drug Product Engineering department. The Associate DP MSAT Engineer supports equipment selection, CMO selection strategy, management of equipment qualification and process validation activities, and will be hands‑on solving issues during technology transfer and cGMP start‑up. The MSAT team establishes best practices for technical support of cGMP drug product manufacturing operations. The Associate DP MSAT Engineer also provides floor support during operations of off‑site manufacturing, reviews process data to ensure operational consistency after the processes are successfully transferred and provides support for investigations.
Typical Responsibilities:
Provides drug product manufacturing process knowledge for new product introduction, technology transfer, process troubleshooting and issue resolution.
Acts as the technical lead, with the support of cross‑functional teams, for technology transfer of the drug product manufacturing processes to manufacturing facilities.
Tracks and reports project milestones related to raw material/component procurement, equipment readiness, analytical process transfer, manufacturing document creation, etc.
Reviews and approves cGMP batch documentation (e.g. master batch records, component specifications, validation protocols, material specifications, etc.) required to support cGMP production at manufacturing facilities.
Assists with investigation and root cause determination and identifies/implements CAPA for manufacturing deviations.
Trends process performance and collaborates with internal and external teams to establish/improve process capability to ensure process is operating within intended process control strategy and within cGMP operations.
Authors policies, technical reports/protocols, change controls, etc. in support of cGMP activities.
Supports development of sampling plans for GMP batches related to lot release, stability and characterization.
Assists in equipment selection, qualification and start‑up activities.
Works with Manufacturing to ensure robust procedures are utilized for operation of equipment.
Partners with Strategic Sourcing/Procurement to specify technical requirements associated with raw materials, components, equipment and services to ensure external vendor on‑time delivery.
Maintains required training status on Regeneron specific work instructions and SOPs.
Travels to contract manufacturers or business partners, as required, up to 25‑50%.
Qualifications & Requirements:
Have experience interacting with Contract Manufacturing Organizations.
Demonstrate technical knowledge in drug product manufacturing, product development and validation.
Have knowledge of industry practices and regulations (cGMP, Annex I) and across multiple health authorities (e.g. FDA, EMA, MHRA, etc.).
Possess strong project management, interpersonal, cross‑cultural, communication, negotiation and problem‑solving skills required.
You must be willing and able to work Monday‑Friday, 8:00am‑4:30pm and are willing to travel. You must have a BS in Packaging Engineering, Biomedical Engineering, Mechanical Engineering or related Engineering field and 0‑2 years of experience.
Salary Range (annually):
$62,355.00 - $92,400.00
Seniority Level Entry level
Employment Type Full‑time
Job Function Engineering and Information Technology
Industries Biotechnology
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. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
Referrals increase your chances of interviewing at Regeneron by 2x.
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Typical Responsibilities:
Provides drug product manufacturing process knowledge for new product introduction, technology transfer, process troubleshooting and issue resolution.
Acts as the technical lead, with the support of cross‑functional teams, for technology transfer of the drug product manufacturing processes to manufacturing facilities.
Tracks and reports project milestones related to raw material/component procurement, equipment readiness, analytical process transfer, manufacturing document creation, etc.
Reviews and approves cGMP batch documentation (e.g. master batch records, component specifications, validation protocols, material specifications, etc.) required to support cGMP production at manufacturing facilities.
Assists with investigation and root cause determination and identifies/implements CAPA for manufacturing deviations.
Trends process performance and collaborates with internal and external teams to establish/improve process capability to ensure process is operating within intended process control strategy and within cGMP operations.
Authors policies, technical reports/protocols, change controls, etc. in support of cGMP activities.
Supports development of sampling plans for GMP batches related to lot release, stability and characterization.
Assists in equipment selection, qualification and start‑up activities.
Works with Manufacturing to ensure robust procedures are utilized for operation of equipment.
Partners with Strategic Sourcing/Procurement to specify technical requirements associated with raw materials, components, equipment and services to ensure external vendor on‑time delivery.
Maintains required training status on Regeneron specific work instructions and SOPs.
Travels to contract manufacturers or business partners, as required, up to 25‑50%.
Qualifications & Requirements:
Have experience interacting with Contract Manufacturing Organizations.
Demonstrate technical knowledge in drug product manufacturing, product development and validation.
Have knowledge of industry practices and regulations (cGMP, Annex I) and across multiple health authorities (e.g. FDA, EMA, MHRA, etc.).
Possess strong project management, interpersonal, cross‑cultural, communication, negotiation and problem‑solving skills required.
You must be willing and able to work Monday‑Friday, 8:00am‑4:30pm and are willing to travel. You must have a BS in Packaging Engineering, Biomedical Engineering, Mechanical Engineering or related Engineering field and 0‑2 years of experience.
Salary Range (annually):
$62,355.00 - $92,400.00
Seniority Level Entry level
Employment Type Full‑time
Job Function Engineering and Information Technology
Industries Biotechnology
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. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
Referrals increase your chances of interviewing at Regeneron by 2x.
#J-18808-Ljbffr