at Merck in Springfield, Illinois, United States
Job Description
Job Description
Our company is a global biopharmaceutical leader with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products.
We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world’s biggest investors in Research & Development.
Employees within the Regulated PK/ADA Bioanalytical Outsourcing group provide oversight for outsourcing of regulated clinical and preclinical assay method development, validation, and sample testing in support of biologics and small-molecule programs. This group is seeking a dynamic and collaborative employee with established scientific experience in large and small molecule bioanalytical assay development and validation as well as people management/mentoring experience and general project management skills to provide operational and logistical oversight for bioanalytical outsourcing. Oversight will include Pharmacokinetics (PK), Anti- Drug Antibody (ADA), and Neutralizing antibody (Nab) assays. Job responsibilities will support third party lab operational oversight and associated activities including management of assay transfer and validations, study sample analysis contracting, relationship management, meeting organization, and vendor performance to ensure quality, timeliness and compliance of outsourced bioanalytical work.
PLEASE NOTE THAT THIS IS NOT A LABORATORY-BASED POSITION.
Specific Responsibilities include:
+ Contribute to overall group strategy in line with PCD and our Research and Development Division strategies. Set and deliver on annual group objectives in line with strategy.
+ As a senior scientist in the group, mentor junior scientists on solving complex problems independently while helping them gain confidence in decision making. Help team members to build relationships with Subject Matter Experts (SMEs) which guide the science and achieve company quality expectations.
+ Maintains a contemporary knowledge of Regulatory and GLP requirements and ensures externally supported work is following the latest regulatory requirements.
+ Assist in forecasting annual budget, reporting quarterly actuals vs. plan, and meeting budget within pre-specified bounds. Align with functional areas to understand needs and align with finance.
+ Contribute in managing overall vendor relationships with Contract Research Organizations (CROs). Participate in Site Visits providing insight into future strategy and building/maintaining relationships.
+ Proactive in awareness of vendor talents/abilities and the development of strategic sourcing plans to ensure sustained business continuity.
+ Ensure team members understand and comply with all safety and company policies/procedures.
+ Collaborating and coordinating extensively and effectively across functions, both internally and externally, to achieve program deliverables as part of a team.
Education Minimum Requirement:
+ PhD in Biology, Cell Biology, Virology, Immunology, Biochemistry, Chemistry or related field with 4+ years of relevant bioanalytical experience; or Master’s degree with 8+ years of relevant experience, or Bachelor’s degree with 12+ years of relevant experience.
Required Experience and Skills:
+ Bioanalytical experience with regulated ligand binding assays (e.g. PK, ADA and Nab) cell-based functional and neutralization assays, molecular assays, and LC/MS assays, with knowledge of regulatory agency requirements for operating in a regulated environment.
+ Employee management or mentoring experience.
+ Ability to work independently and within a cross-functional team.
+ Excellent leadership, technical, communication (oral and written), interpersonal, and teamwork skills.
+ Self-motivated with a positive attitude and proven performance record.
+ Demonstrated leadership, coaching and mentoring skills required.
Preferred Experience and Skills:
+ 8+ years of experience working in a regulated bioanalytical environment and familiarity with FDA bioanalytical guidance requirements.
+ Project Management Experience
+ Vendor relationship management experience
+ Experience with negotiation of timelines and project demands
Location:
+ West Point, Pennsylvania or Kenilworth, New Jersey
+ Travel Requirements: 20%
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.
Current Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld)
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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.
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:
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