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Associate Principal Scientist, Biologics Process Development

Merck

Merck

West Point, PA, USA
Posted on Wednesday, April 17, 2024

Job Description

Our Research Scientists are our Inventors. Using innovative thinking, state-of-the-art facilities, and robust scientific methodology, we partner to deliver the next medical breakthrough.

BPR&D within Our Research Laboratories is on a mission to rapidly deliver diverse biotherapeutics to patients by efficiently developing innovative, robust manufacturing processes and technologies. To achieve this, we work closely with colleagues in Discovery, Pre-clinical, Early Development, Analytical, Formulation, and Commercial Manufacturing while providing a diverse and inclusive environment for all. Beyond process development for pipeline biologics, we innovate and build next generation biomanufacturing technologies. Examples include investments for development of continuous manufacturing, green and sustainable processes, and proprietary technology platforms. We actively publish and engage with the scientific community to influence the field.

We are seeking a highly motivated and energetic individual to join our Biologics Process Development Department as Associate Principal Scientist. In this role, the successful candidate will work closely with highly motivated team of Scientists and Engineers in the Upstream Process Development area and contribute to CMC development of our company's pipeline, playing an active role in design, development and optimization of cell culture processes and transfer processes to clinical and commercial manufacturing sites. You will also participate in developing and refining strategies related to next generation processes through technology development initiatives for assets in early and late-stage clinical development.

Responsibilities include, but not limited to:

  • Participate in and/or lead upstream development of first-in-human and commercial processes by efficiently developing high yield, robust and scalable cell culture processes.

  • Responsible for process characterization and regulatory filing activities to ensure a smooth and clear path to successful commercialization.

  • Collaborate with downstream process development, Analytical R&D, and other cross-functional teams in both Research and Manufacturing to advance biologics pipeline

  • Advance and improve upstream platform processes through creative initiatives that increase operational efficiency and reduce costs.

  • Assess new technologies, and industry strategies that are relevant to our company

  • Collaborate with academia, industry partners, and vendors to drive development, innovation, and adoption of new technologies.

  • Keep up to date with the external patents and literature; actively present and publish externally and pursue patenting strategies.

  • Mentor junior scientists.

MINIMUM EDUCATION REQUIREMENTS:

  • Ph.D. with 3+ years OR Master’s with 6+ years OR B.S. with 8+ years of industry experience and background in chemical engineering, Bioengineering, Biological Engineering, or a related field

REQUIRED EXPERIENCE AND SKILLS:

  • Technical background and hands-on experience with mammalian cell culture and fed-batch processes to produce recombinant proteins.

  • Scientific understanding and working knowledge of mammalian cell biology, metabolism, cell culture media and engineering principles for large scale recombinant protein production systems.

  • Working knowledge of statistical methods (design of experiments, multivariate data analysis) and tools (SIMCA, JMP, etc.).

  • Understanding of cell culture bioreactor performance and principles across scales

  • Track record of accomplishments in upstream process and technology development with a strong scientific publication and presentation history

  • Excellent verbal, written communication, and interpersonal skills.

  • Ability to work effectively in cross-functional and matrixed team environment; collaborate with both internal and external partners including vendors.

  • Demonstrated ability for taking initiative, creativity, and innovation in problem solving.

  • Capacity for team leadership

PREFERRED EXPERIENCE AND SKILLS:

  • Cell culture media development.

  • High throughput microbioreactor systems and advanced in situ analytics for process monitoring and control.

  • State-of-the-art cell culture processes including intensified inoculum/fed-batch and perfusion process development.

  • Data science approaches related to cell culture and predictive modeling e.g., (metabolic flux analysis, omics, machine learning; integration of process analytical technologies).

  • Knowledge of biologics CMC development cycle, scale-up, scale-down model qualification, process characterization, and technology transfer to manufacturing sites.

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

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.

#BPRD #PRD #EligibleforERP

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

Current Employees apply HERE

Current Contingent Workers apply HERE

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 if you need an accommodation during the application or hiring process.

We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights

EEOC GINA Supplement​

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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.

Learn more about your rights, including under California, Colorado and other US State Acts

U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.

Expected salary range:

$135,500.00 - $213,400.00

Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here.

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, 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:

Domestic

VISA Sponsorship:

Yes

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Not Applicable

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

N/A

Job Posting End Date:

06/21/2024

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.


Job Posting End Date:06/21/2024


A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.


Requisition ID:R291203