Executive Director, Biologics Analytical Research and Development

Executive Director, Biologics Analytical Research and Development

Apply promptly! A high volume of applicants is expected for the role as detailed below, do not wait to send your CV.

Apply remote type Not Applicable

locations USA - New Jersey - Rahway

time type Full time

posted on Posted 4 Days Ago

time left to apply End Date : January 27, 2025 (15 days left to apply)

job requisition id R301118

Job Description

Our Research Scientists are our Inventors. We identify and target steps in disease mechanisms or pathways that could be inhibited or enhanced. Our goal is to isolate a compound that is effective against a disease target. Using innovative thinking, state-of-the-art facilities and robust scientific methodology we collaborate to discover the next medical breakthrough.

Our team in Rahway, New Jersey, is seeking an exceptional leader who is passionate about leading a team of Scientists to deliver analytical solutions that enable and accelerate process and product development and manufacturing and ensure safety and quality of our products. The successful candidate will be accountable for proactive resourcing planning, risk assessment strategies and will focus on talent development and partnering to build an integrated culture of innovation across modalities and will partner with cross-functional development teams to enable pipeline decisions.

The Executive Director, Biologics Analytical Research and Development (B-AR&D) is responsible for providing strategic and technical leadership for analytical development of candidates from the discovery interface, through first product registration. They will be responsible for a portfolio of Biologics programs (approximately 10-15 programs), and leading multiple Director lead Development teams, overall approximately 40-50 scientists. Strategic partnering with Biologics Analytical Research and Development method development GMP laboratories, complementary areas of Analytical Research and Development, Biologics Process Research and Development, CMC and Regulatory in aspects of control strategy and filings, Quality and our partners in the commercialization and manufacturing is essential.

The successful candidate must function well and be able to collaborate in a fast-paced, integrated, multidisciplinary team environment. Research and industry experience should demonstrate successful application and management of state-of-the-art analytical techniques to solve problems, including strong background and experience in separations science, extensive experience with UPLC / HPLC analysis of biologics (e.g. SEC, RP, IEX), experience in microbiological techniques, ELISA, PCR, cell based analytics, background in analytical methodologies and sound scientific understanding of Critical Quality Attributes / QbD / DOE principles as well as data analysis and statistics for setting specifications. The incumbent will be responsible for the recruiting, appraisal and development of personnel under their supervision.

The Executive Director selects, trains, and effectively works with colleagues to action development plans of personnel under their direction within the framework of Company policy. The Executive Director will be a manager of managers, with keen focus on coaching and mentoring organizational leaders in talent Development. The role will also be responsible for proactive resourcing planning, risk assessment strategies and budget management as necessary (including merit and promotion planning). Maintaining a strong network internally and across the external academic and regulatory community is expected, as well as advancing a culture of scientific excellence, compliance mindset and collaboration with various partners and stakeholders in development.

Education :

BS Degree with 17 years of relevant experience or MS with 10 years of relevant experience or Ph.D. in analytical chemistry or related field with 8 years of relevant experience in the pharmaceutical industry

Required Experience and Skills :

Excellent verbal and written communication skills, demonstrated creativity, strong interpersonal and collaborative skills

Demonstrated ability in leading cross-functional groups with proven talent development skillsets.

Ability to work in a team environment with cross-functional interactions is essential

Strength in delivering results on firm deadlines in support of compound from development through Commercialization

A strong aptitude for and previous experience in managing inclusive scientific teams and attracting, developing, and retaining diverse talent.

Extensive knowledge of and hands-on work in applying regulatory guidance and quality standards related to product release and safety.

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.

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.

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.

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 :

243,500.00 - $383,300.00

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.

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Salary : $243,500 - $383,300