Merck Hiring for Associate Principal Scientist, Engineering at Dover, Delaware Full Time

Job Description

If this position will be based in the US or Puerto Rico (not applicable to positions based outside of US or Puerto Rico): Subject to applicable law, all prospective hires will be required to demonstrate that they have been fully vaccinated for COVID-19 or intend to be vaccinated for COVID-19 by November 1, 2021, or qualify for a medical or religious accommodation to this vaccination requirement. Hired candidates who are not vaccinated by November 1, 2021, and who have not been approved for a legally-required medical or religious accommodation will be subject to disciplinary action up to and including termination of employment, subject to applicable law.

Our Engineers sponsor internal and external manufacturing operations remain operational, continuously improve, and innovate. With our extensive range of facilities and environments, our Engineers have opportunities across many diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Validation.

As part of our Manufacturing Division, the Biologics Process Development & Commercialization (BPDC) department provides the Drug Substance technical process direction and laboratory capabilities in sponsorship of late-stage pipeline and commercial manufacturing processes for biologics (therapeutic proteins). Within BPDC Process Engineering, we partner across areas of the Manufacturing Division and cross-divisionally with our Research & Development Division with the goal of delivering innovative products to patients.

For pipeline programs, BPDC Process Engineering steers various commercialization activities, including technology transfer to internal and external manufacturing sites, process validation, and authoring of regulatory submissions. For commercial programs, the scope includes promotion of site-to-site process transfers, process enhancements, next generation process (i.e., post approval) development and process characterization, process validation, and regulatory submission authoring. Through process engineering, we ensure that our company’s biologics processes can be scaled up or scaled out into the manufacturing facilities with our respective partners.

Under the general scientific and administrative direction of a Director, Biologics Process Engineering and working in conjunction with internal and external partners, this colleague will promote late stage and commercial biologics program activities within BPDC. This person will demonstrate scientific, experimental and technology transfer skills primarily focusing on upstream processing while collaborating with partners to drive downstream processing, analytical and overall process modeling activities.

Position tasks and knowledge:

• Provides technical direction for technology transfer, process validation/PPQ, facility fit, risk assessments, manufacturing campaigns, process and plant modeling, regulatory filings (IND/BLA/PAS) and post approval life cycle management.

• Provides technical influence in the interpretations of trends observed in commercial process monitoring (e.g., statistical process control (SPC) and/or multivariate analyses (MVA))

• Provides technical influence for technical investigations and process changes that seek to drive improvements to yield and/or robustness.

• Partners with laboratory on the design of experiments, data analysis and interpretation of bench/pilot scale studies to promote technology transfer and process characterization.

• Directs the effort with multiple functions, including the manufacturing site, to establish the commercial process description and integrated control strategy.

• Primary focus will be on drug substance upstream processing, but position requires a working knowledge of the various aspects of product manufacture and functional area interdependencies, including downstream, analytical and drug product process.

• Actively interacts with internal and external counterparts. Represents functional area on cross-functional and cross-divisional teams and directs technical teams through matrix and direct management structures.

• Authors regulatory and technical documentation. Ensures that process/product are developed and documented according to standard of our Company practices.

• Influence in workforce planning, talent development and people management

Education:

• BS, MS, or PhD in Biological Sciences/Chemical Engineering/Biological Engineering/Chemistry with 10 years for BS, 8 years for MS, or 4+ years for PhD of relevant industry knowledge.

Industry Knowledge and Skills:

• Cell culture to produce biological molecules from mammalian-based expression systems, with an in-depth knowledge of seed expansion, production bioreactor (fed-batch and perfusion mode) and harvest.

• Demonstrated comprehension of the fundamentals and/or modeling of unit operations.

• Management knowledge with late-stage process development, process characterization, technology transfer, facility fit assessments, commercial control strategy, process validation/PPQ, manufacturing site readiness and regulatory submissions (IND, BLA, PAS).

• Direct knowledge working with internal and external contract manufacturing organizations.

• Technical operations knowledge in the manufacture of biological molecules at the pilot- and commercial-scale.

• Excellent oral and written communication skills.

• Prior matrix and/or people management.

Preferred industry knowledge and Skills:

• Working comprehension of analytical methods to characterize biologics.

• Prior working knowledge with PAI, regulatory inspections and working knowledge of cGMPs.

• Working knowledge of statistical methods for DOE design and data analysis(e.g., JMP or Design Expert software).

• Working knowledge of statistical process control (SPC), multivariate analysis (MVA), and/or process analytical technologies (PAT) techniques for biologics processes.

Our Manufacturing & Supply Division is committed to be the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create an interdependent global manufacturing network that’s committed to delivering a high quality, reliable supply to customers and patients on time, every time.

Who we are …

We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

What we look for …

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers’ Policy – Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

Current Employees apply HERE (https://wd5.myworkday.com/msd/d/inst/1422$1533/rel-task/3001$14.htmld)

Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (https://survey.sogosurvey.com/r/aCdfqL) if you need an accommodation during the application or hiring process.

For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Poster (https://www.dol.gov/sites/dolgov/files/ofccp/regs/compliance/posters/pdf/eeopost.pdf)

EEOC GINA Supplement​

OFCCP EEO Supplement (https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf)

Pay Transparency Nondiscrimination

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

Search Firm Representatives Please Read Carefully

Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

25%

Flexible Work Arrangements:

Remote Work

Shift:

Not Indicated

Valid Driving License:

Yes

Hazardous Material(s):

Number of Openings:

1

Requisition ID: R142535