Description

Janssen Research & Development, LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for a Scientific Director, Bioanalytical Outsourcing and Vendor Management. The preferred locations are Spring House, PA or Beerse, Belgium. Remote work options within North America (East Coast) or Europe may be considered on a case-by-case basis and if approved by the company.

At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.

Janssen Research & Development, LLC discovers and develops innovative medical solutions to address unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, cardiovascular and metabolism, and pulmonary hypertension. Please visit http://www.janssenrnd.com for more information.

The Scientific Director, Bioanalytical Outsourcing and Vendor Management for the External Sourcing and Pipeline Management group within the Bioanalytical Discovery and Development Sciences (BDDS) organization, will support externalization of bioanalytical work globally. The BDDS organization develops, validates, and conducts bioanalytical sample analysis across the therapeutic portfolio (all modalities) from discovery through development. This individual will partner closely with the head of the group to build and implement our outsourcing strategy. Collaborate with functional leaders within BDDS to ensure project alignment on strategy and prioritization.

The Scientific Director will demonstrate expertise across a broad range of bioanalytical techniques that includes LC/MS, LBA, molecular PCR (qPCR), and cell-based assays to: 1) ensure that the work can be externalized in a proactive manner ensuring high quality data, timely delivery, and competitive pricing; 2) provide leadership for bioanalytical work placed in China through close partnership with the local Janssen group in China; 3) understand the contract laboratory landscape. This leader will demonstrate experience collaborating with external vendors and a record of delivering results. Keep abreast of regulatory guidelines related to bioanalytical method validations and sample analyses to meet global health authority filing requirements. This role will require international travel to North America, Europe, and Asia.

The Scientific Director will have leadership responsibility in Spring House, PA and Beerse, Belgium and a dotted-line reporting relationship to a group located in China. Support the personal development of all employees within their group as well as the broader team. This leader will be a role model of the company’s dedication to equal employment opportunity and the value of a diverse workforce.

Key Responsibilities:

• Build and lead a diverse and complementary team of scientists.
• Proactive plan and prioritize work to support key portfolio targets.
• Provide scientific mentorship and coaching to staff.
• Monitor BDDS external supplier performance.
• Coordinate quarterly governance meetings with our key external suppliers.
• Ensure adequate external supplier capacity.
• Establish processes for timely supply of test articles and critical reagents to external partners.
• Confirm clinical sample reconciliation prior to database lock.
• Travel as needed to external suppliers and actively participate in on-site audits.
• Adapt quickly to transforming needs of the development portfolio and work collaboratively across functions in BDDS, Clinical, Regulatory Affairs, and the Quality Organization.
• Collaborate with leaders and peers in other BDDS teams to craft and implement outsourcing strategy.
• Anticipate bioanalytical outsourcing needs and develop proactive strategies and executable plans to ensure seamless external support.
• Build and maintain positive relationships with external partners.
• Review vendor scorecards and proactive address areas of concern.
• Evaluate vendors for bioanalytical platform assessments based on increased capacity or novel techniques.
• Leverage internal and external expertise to ensure high quality data, timely delivery, and drive innovation.
• Communicate issues to key partners that highlight risks and mitigation strategies
• Exhibit strong technical writing skills.
• Contribute to strategic and long-range planning for BDDS and staff development/needs.
• Proactively collaborate with business operations, procurement, and legal partners to ensure compliance, quality, and value of our external partners.

Qualifications

• A minimum of a Bachelor’s degree in Chemistry, Biochemistry, Biology, or a related scientific field is required. Advanced degree (Master’s, Ph.D.) in a scientific field is preferred.
• A minimum of 15 years of pharmaceutical industry or contract research organization (CRO) experience with a Bachelor’s degree; a minimum of 12 years of pharmaceutical industry or contract research organization (CRO) experience with a Master’s degree; or a minimum of 9 years of pharmaceutical industry or contract research organization (CRO) experience with a Ph.D. degree is required.
• Prior managerial experience with 3+ direct reports in a pharmaceutical or CRO bioanalytical group is required.
• Prior direct hands-on experience developing and implementing bioanalytical assays is required.
• Experience leading cross-functional teams with a track record of developing and implementing strategies to tackle problems is required.
• GxP experience is highly preferred.
• Expertise in relevant bioanalytical regulatory guidelines is required.
• Vendor management experience is required.
• Must have excellent oral and written communication skills.
• Must have strong organizational and process management skills.
• Must have strong negotiation skills.
• The ability to troubleshoot common bioanalytical issues encountered in the laboratory is required.
• The ability to collaborate with all levels and influence decision-making across the organization is required.
• This position will require up to 25% domestic and international travel.

The anticipated base pay range for this position in the San Francisco Bay Area, CA is $193,000 to $312,110.

The anticipated base pay range for this position in all other US locations is $157,000 to $271,400.

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/ performance year. Bonuses are awarded at the Company’s discretion on an individual basis.

Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.

Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).

Employees are eligible for the following time off benefits:

• Vacation - up to 120 hours per calendar year
• Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year
• Holiday pay, including Floating Holidays - up to 13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year

For additional general information on company benefits, please go to: https://www.careers.jnj.com/employee-benefits

* The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.