Associate Director, Method Development Bioanalytical Chemistry

Job Summary

The Associate Scientific Director (ASD) in Bioanalytical Chemistry oversees the scientific conduct of all projects/programs within the group. The role includes oversight of the method development activities and discovery programs. It involves leading strategic initiates for the purpose of growth in services, staff development, and promoting external scientific visibility. The ASD is directly involved in and/or directing scientific mentoring and coaching across the group. Lastly, the ASD is a key participant in achieving revenue target goals and in building and retaining sponsor relationships. In all cases the Associate Scientific Director works within the expectations for proper study conduct as determined by SOPs and the SD/Pl/Management.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Support and build upon the overall technical strength in the bioanalytical group by providing input and guidance on approach, conducting background research, doing feasibility, and drawing on a depth of personal expertise.
• Lead the method development and discovery services groups
• Ensure methods from the method development are fit-for-purpose, and ready for FDA/EMA validation guidelines (where appropriate).
• Ensure on-time and quality delivery for non-GLP/discovery study support
• Coach and mentor, the development of staff in these groups for continued technical growth
• Direct the development of novel scientific approaches, including providing creative input on developing new assay platforms and service offerings.
• Contribute to a scientific strategy that includes external visibility at conferences, including poster, podium talks, and publications
• In concert with the Director, contribute to the overall bioanalytical day-to-day activities, i.e. reviewing program and project data, providing regulatory guidance, and general support for junior staff, as appropriate and required.
• Contribute to the proposal/bidding process and wining new sponsors/work
• Directly work with sponsors providing project updates, overviews, and guidance
• Contribute to the development of department plans and long-term goals/vision (i.e. growth plans, revenue goals, process improvements, new software/instrument infrastructure)
• Coach and mentor across all bioanalytical staff to increase the technical proficiency of the group
• Present and/or contribute to presentations, scientific and operational, to internal and external WIL groups
• Routinely serve as a lead representative of the bioanalytical department, internally and externally
• Review and sign as management on reports, deviations, etc.
• Contribute SOP and compliance infrastructure, as appropriate

Job Qualifications

• Education: Bachelor’s degree (B.A./B.S.) or equivalent in a scientific related discipline preferred. Master’s Degree in, chemistry or a related scientific discipline recommended. Ph.D. preferred.
• Experience: 5 years relevant laboratory experience in a contract research organization (CRO), biotechnology, or pharmaceutical environment, working to Good Laboratory Practice (GLP) standards. 3 years management experience, including staff management and development, and financial responsibility including budgets.
• Certification/Licensure: None.
• Other: Understanding PK/TK and metabolic processes
• Significant depth of knowledge in regulatory compliance (FDA/EMA/EPA) as relates to bioanalytical sciences

PHYSICAL DEMANDS:

• Must be able to lift, move, manipulate and/or hold heavy objects up to and including 50 pounds; this includes work materials, equipment, and/or supplies.
• Must be able to perform procedures, standing or sitting, for long periods of time, using appropriate instruments, reaching with hands and arms, working in narrow spaces, and wearing safety equipment (PPE) according to OSHA regulations and company standards.
• Must be able to frequently hold and manipulate work materials while utilizing fine motor skills.
• Must be able to regularly provide information to and receive information from/through various technologies, media, sources, and contacts. Must be able to accurately exchange information in these situations.
• Regularly operates a computer and other office productivity machinery, such as a calculator, copy machine, and computer printer.
• Move about inside the work area to access file cabinets, office machinery, etc.
• Specific vision abilities required by this job include close vision, color vision, depth perception, and the ability to adjust focus.

WORK ENVIRONMENT:

• General office and lab working conditions, the noise level in the work environment is usually quiet.
• While performing the duties of this job the employee is regularly required to wear protective clothing (i.e., goggles, face shield, cap, gloves, scrubs, shoe covers), work near toxic or caustic chemicals, work with biohazards.
• The employee may occasionally be exposed to live animals with risk of exposure to allergens, zoonotic disease, and biohazards.
• The employee may occasionally be exposed to fumes or airborne particles, unpleasant odors, and extreme temperature conditions.
• The noise level in the work environment ranges from low to moderate depending upon the task being performed.

COMMENTS:

• This position may require occasional travel.

Compensation Data

The pay range for this position is $130,000/yr. - $140,000/yr. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.

Competencies