Principal Engineer (Drug Product) Position Available In Rensselaer, New York

Job Description:

We are currently looking to fill a Principal Drug Product (DP)Manufacturing Science and Technology (MSAT) Engineer position. TheDrug Product (DP) Manufacturing Science and Technology (MSAT)Engineer supports and/or leads equipment selection, CMO selectionstrategy, management of equipment qualification and/or processvalidation activities and will be hands-on solving issues duringtechnology transfer and cGMP start-up. The MSAT team establishesbest practices for technical support of cGMP drug productmanufacturing operations. The Engineer also provides floor supportduring operations of internal or external manufacturing, reviewsprocess data to ensure operational consistency after processes aresuccessfully transferred and provides support for investigations.

In this role, a typical day might include the following: Providesdrug product manufacturing process knowledge and oversight for newproduct introduction, technology transfer, process troubleshootingand issue resolution. Acts as the technical lead and subject matterexpert for technology transfer of the drug product manufacturingprocesses to manufacturing facilities. Tracks and reports projectmilestones related to raw material/component procurement, equipmentreadiness, analytical process transfer, manufacturing documentcreation, etc. Reviews and approves cGMP batch documentation (e.g.master batch records, component specifications, validationprotocols, material specifications, etc.) required to support cGMPproduction at manufacturing facilities. Assists with investigationand root cause determination and identifies/implements CAPA formanufacturing deviations. Trends process performance toestablish/improve process capability to ensure process is operatingwithin intended process control strategy. Authors policies,technical reports/protocols, change controls, etc. in support ofcGMP activities. Supports development of sampling plans for GMPbatches related to lot release, stability and characterization.

Partners with and/or leads cross-functional internal/external teamsto ensure process transfer execution Collaborates with internal andexternal teams to identify opportunities to improve processperformance and cGMP operations. Assists with and/or leads inequipment selection, qualification and start up activities. Workswith Manufacturing to ensure robust procedures are utilized foroperation of equipment. Partners with StrategicSourcing/Procurement to specify technical requirements associatedwith raw materials, components, equipment and services to ensureexternal vendor on time delivery. Ensures product integrity andcompany reputation by assisting in the monitoring of cGMPcompliance at drug product contract manufacturers. Maintainsrequired training status on Regeneron specific work instructionsand SOPs. Works with DP MSAT management to define theorganizational structure, identify and prioritize strategicinitiatives to improve efficiency and compliance and assess humanresource structure and requirements to meet growth projections.

Leverages subject matter expertise to resolve issues that may ariseand escalates to line management in a timely way to manage impact.

Travels to contract manufacturers or business partners, asrequired, up to 25-50%. This role might be for you if: Experienceinteracting with Contract Manufacturing Organizations. Demonstratedtechnical knowledge in drug product manufacturing, productdevelopment and validation. Knowledge of industry practices andregulations (cGMP, Annex I) and across multiple health authorities(e.g. FDA, EMA, MHRA, etc.). Strong project management,interpersonal, cross-cultural, communication, negotiation andproblem-solving skills required. To be considered for the PrincipalEngineer you must have a BS in engineering and 8 years ofexperience in a pharmaceutical / biologics cGMP environment orequivalent combination of education and experience. To beconsidered for the Staff Engineer you must have a BS in engineeringand 10 years of experience in a pharmaceutical / biologics cGMPenvironment or equivalent combination of education and experience.

Does this sound like you? Apply now to take your first step towardsliving the Regeneron Way! We have an inclusive and diverse culturethat provides comprehensive benefits, which often include(depending on location) health and wellness programs, fitnesscenters, equity awards, annual bonuses, and paid time off foreligible employees at all levels! Regeneron is an equal opportunityemployer and all qualified applicants will receive considerationfor 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 Travelercommunity, 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 characteristicin accordance with applicable laws and regulations. The Companywill also provide reasonable accommodation to the knowndisabilities or chronic illnesses of an otherwise qualifiedapplicant for employment, unless the accommodation would imposeundue hardship on the operation of the Company’s business. Forroles in which the hired candidate will be working in the U.S., thesalary ranges provided are shown in accordance with U.S. law andapply to U.S.-based positions. For roles which will be based inJapan and/or Canada, the salary ranges are shown in accordance withthe applicable local law and currency. If you are outside the U.S,Japan or Canada, please speak with your recruiter about salariesand benefits in your location. Please note that certain backgroundchecks will form part of the recruitment process. Background checkswill be conducted in accordance with the law of the country wherethe position is based, including the type of background checksconducted. The purpose of carrying out such checks is for Regeneronto verify certain information regarding a candidate prior to thecommencement of employment such as identity, right to work,educational qualifications etc. Salary Range (annually) $90,800.00- $173,400.00