FreshRemote.Work

Senior Specialist, Biologics Downstream Operations

USA - New Jersey - Rahway

Job Description

Job Description: 

We are seeking an experienced and motivated scientist/engineer to join the Biologics Downstream Operations team within BioProcess Research and Development (BPRD).   The successful candidate will be charged with operations leading downstream pilot plant activities, including fed-batch, antibody-drug conjugate processing and continuous processing operations. The candidate may have the opportunity to identify operational improvements to increase efficiency, respond to non-standard requests, or implement new technology and update laboratory procedure documents to standardize the improvement. Candidate is expected to work in a team atmosphere in close collaboration with bioprocess development scientists, facility engineering, lab automation and safety groups. 

The ideal candidate should have experience with small - scale and/or large - scale bioprocess equipment, including bioprocess chromatography skids, normal and tangential flow filtration techniques, viral filtration & inactivation techniques.  The incumbent must be able to lead a small team (3-5 persons), work well with others, and communicate effectively both written and orally. Candidate may be requested to work during non-business hours/days to support extended growth and production activities. 

Candidate will participate in a range of activities including, but not limited to:

  • Oversee purification activities for a range of biologics therapeutic molecules, including but not limited to mAb, fusion proteins, and antibody-drug conjugates.

  • Facilitate knowledge transfers between development and operations teams.

  • Batch documentation within an electronic laboratory notebook system.

  • Participate in scheduling discussions within the operations team and scientists.

  • Collaborate with development colleagues on the implementation of novel technologies and process analytical tools.

  • Work collaboratively with pilot plant operations, upstream and solution prep teams.

  • Work collaboratively with process development scientists from across BPR&D.

  • Support safety and training initiatives.  

Education: 

  • MS in Chemical/Biochemical/Biomedical Engineering/Biology/Chemistry with 5+ year or BS with 7+ years of hands-on industry experience

Required Experience and Skills: 

  • Strong skills in laboratory experimentation and documentation, with demonstrated ability to write clear comprehensive operating procedures. 

  • Solid hands-on experience with large scale purification operations 

  • Ability to lead a team.

  • Proven record of training peers.

  • Strong communication and interpersonal skills to work in cross-functional team environments. 

  • Strong troubleshooting skills.

Preferred Experience and Skills: 

  • Experience with Bioprocess Skid and BioSMB

  • Experience with Akta Ready/Flux

  • Experience with Pendotech TFF System

  • Experience with both fed batch and continuous processing.

  • Experience with DeltaV, and Unicorn

  • Ability to work with lab automation teams on improvement projects.

#EBRG #vetjobs #eligibleforerp #PRD

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

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​

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.

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, Monday - 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”.

The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. 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 US salary range:

$111,400.00 - $175,300.00

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.

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

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:

No relocation

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Not Applicable

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

N/A

Job Posting End Date:

11/12/2024

*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.

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Job Profile

Regions

North America

Countries

United States

Restrictions

Hybrid Hybrid work Hybrid work model Must have 12 months in current position before applying On-site Puerto Rico residents only Separation benefits eligibility US and Puerto Rico residents only

Benefits/Perks

Bonus eligibility Diverse workplace Equal opportunity employer Flexible work Flexible work arrangements Hands-on experience Hybrid work Hybrid work model Inclusion Inclusive environment Insurance Paid holidays Retirement benefits Separation benefits package Sick Days Vacation

Tasks
  • Batch documentation
  • Collaborate with development teams
  • Collaboration
  • Communication
  • Compliance
  • Document batch processes
  • Identify operational improvements
  • Innovation
  • Lead a Team
  • Lead downstream operations
  • Oversee purification activities
  • Process development
  • Support safety initiatives
  • Troubleshooting
Skills

Analytical Analytical tools Antibody-drug conjugates Automation Biologics Biologics purification Biology Biomedical Engineering Bioprocessing Chemistry Chromatography Collaboration Communication Compliance Continuous Processing Development Documentation Downstream operations Education Engineering Equipment Filtration Filtration techniques Inclusion Innovation Interpersonal Lab Automation Laboratory Laboratory documentation Manufacturing Novel technologies Operational Operations Organization Policy Process Development Purification Research Research and development Safety Scheduling Talent Acquisition Team Leadership Teams Technology Training Troubleshooting Viral filtration

Experience

5 years

Education

AS Automation Biology Biomedical Engineering B.S. Business Chemistry Engineering MS Technology

Timezones

America/Anchorage America/Chicago America/Denver America/Los_Angeles America/New_York Pacific/Honolulu UTC-10 UTC-5 UTC-6 UTC-7 UTC-8 UTC-9