In April 2020, our Company announced plans to consolidate our New Jersey campuses into a single New Jersey headquarters location in Rahway, NJ in 2023 and 2024. Therefore, this role will be temporarily based in Kenilworth and exact timing of the departmental move to Rahway, NJ will be communicated at a future date. Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safe... more details
Job Description
In April 2020, our Company announced plans to consolidate our New Jersey campuses into a single New Jersey headquarters location in Rahway, NJ in 2023 and 2024. Therefore, this role will be temporarily based in Kenilworth and exact timing of the departmental move to Rahway, NJ will be communicated at a future date.
Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine.
Process Cell Sciences (PCS) is seeking a highly motivated and experienced Principal Scientist to help develop and characterize early and late stage mammalian commercial cell lines to support innovative biological pipeline projects.
Position Description:
The successful candidate should have industrial experience related to commercial CHO cell line development. Candidate must have an in-depth understanding of cell biology/molecular biology and hands-on experience of molecular techniques, mammalian culture and next-gene sequencing. Candidate should demonstrate and stay up to date on the knowledge in genomics, transcriptomics, proteomics and genome editing technologies. Candidate must have experience in executing complex study designs requiring highly organized data collection and management.
Primary Responsibilities:
Serve as the subject matter expert in cell line development and technical lead to represent functional area for biologics pipeline programs
Work independently, including proactive planning, trouble shooting and successful execution of complex experimental protocols for cell line development and technology assessment
Complete and effectively manage multiple projects within timelines ensuring that all tasks and responsibilities are carried out according to high scientific and ethical standards.
Interface and collaborate with other functional teams in Discovery, Process development, Analytics, Operation, CRO/CMO outsourcing in the planning, execution, and technical troubleshooting.
Responsible for technical reports and relevant sessions of IND and BLA filing.
manage a team of 4-5 scientists, mentoring and guiding team members on the completion of portfolio and technology projects.
Publications in peer-reviewed scientific journals and external/internal presentations are expected
Position Qualifications:
Education Minimum Requirement:
Required Experience and Skills:
Experienced in developing commercial cell line development (CLD) for recombinant protein expression.
Experienced in coordinate CLD responsibilities for pipeline project and ensure timely communication between CLD and other functional areas within CMC team.
Excellent project leadership skills in driving for results and innovation. Strong communication and interpersonal skills to work in team environment.
Strong knowledge and record of scientific skills in molecular biology, mammalian cell cultures, gene editing. Experienced in vector optimization and/or CHO host cell engineering.
Experienced in regulatory filing and preparing relevant documentation
Excellent oral and written communication skills
Preferred Experience and Skills:
Strong management and leadership experience
Experienced in automation and Flow
Experienced in next generation sequencing (NGS) platform, and high-level understanding of NGS analysis pipeline setup analysis.
Expertise of database and statistical software (e.g. Excel, JMP).
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.
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.
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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:
$164,800.00 - $259,400.00
Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here.
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Employee Status:
Regular
Relocation:
Domestic
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Shift:
Valid Driving License:
Hazardous Material(s):
Job Posting End Date:
05/31/2024
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