Team Lead, Formulation Services

Team Lead, Formulation Services

TITLE AND CLASSIFICATION:  Team Lead, Formulation Services / Exempt Position

REPORTING LOCATION: Rockville, MD

REPORTS TO: Manager, Formulations

PRIMARY OBJECTIVES:  Provide general formulations support and leadership for ongoing and pending In Vivo and Ex Vivo studies.

DUTIES AND RESPONSIBILITIES

• Represent the formulations team at project meetings, including scheduling and coordination of test agent and excipient ordering.
• Responsible for training formulations lab technicians.
• Collect and document pertinent data, including lot information, COA, and MSDS, for the receipt, distribution, preparation and disposition of test compounds, reagents, and carriers/vehicles in compliance with appropriate SOPs and policies.
• Conduct advanced formulation preparation, including all dosage and formulation calculations.
• Prepare and dispose of test materials, vehicles, and reagents according to study protocols and SOPs.
• Prepare labels and related documentation of study procedures.
• Maintain inventory of drugs, reagents, and lab supplies.
• Review draft formulation records for accuracy and recommend drug/dosing regiments.
• Review SDS and client TA Forms for technical, and environmental health and safety considerations.
• Monitor test materials and help maintain facilities for cleanliness, safety, and regulatory compliance. 
• Coordinate cross functional initiatives, including internal and external customer and collaborations.
• Support adverse event investigations.
• Review of draft/final study protocols as required.
• Preparation and review of SOPs related to all formulation processes.
• Scheduling and assignment of daily formulation preparations.
• Scheduling and assignment of other laboratory duties/responsibilities, as required.
• Use computer-based LIMS systems and related software.

KNOWLEDGE, SKILLS, AND ABILITIES

• Strong chemistry and pharmacology knowledge, including dose calculations.
• Ability to work effectively and productively in a team-oriented environment while maintaining a strong sense of accountability, integrity, and confidentiality.
• Creative problem-solving skills and the ability to exercise sound and accurate judgment in making timely decisions.
• Superior planning, organizational, computer, written, and verbal communication skills.
• Ability to work with minimal supervision.
• Ability to assist with other duties and manage multiple studies in a dynamic environment.
• Ability to observe safety and security procedures and relevant regulations and laws.

EDUCATION AND EXPERIENCE

• minimum of BS degree in chemistry, pharmacology, or related field, with minimum of 2 years of related experience.

PHYSICAL DEMANDS AND WORK ENVIRONMENT

• Must be able to sit and use hands to finger, handle and feel
• Must be able to lift and move packages weighing up to 50 pounds
• Must be able to sit for long periods of time using a computer in a typical office environment in a multi-level facility
• Some activities require repetitive motion and reaching, pulling or pushing
• In carrying out the duties of the job there will be frequent exposure to fumes and chemical hazards
• Duties performed routinely require exposure to blood, body fluid and tissue

This job description may be changed to include new responsibilities and tasks or change existing ones as management deems necessary.

Qualifications

KNOWLEDGE, SKILLS, AND ABILITIES

• Strong chemistry and pharmacology knowledge, including dose calculations.
• Ability to work effectively and productively in a team-oriented environment while maintaining a strong sense of accountability, integrity, and confidentiality.
• Creative problem-solving skills and the ability to exercise sound and accurate judgment in making timely decisions.
• Superior planning, organizational, computer, written, and verbal communication skills.
• Ability to work with minimal supervision.
• Ability to assist with other duties and manage multiple studies in a dynamic environment.
• Ability to observe safety and security procedures and relevant regulations and laws.

EDUCATION AND EXPERIENCE

• minimum of BS degree in chemistry, pharmacology, or related field, with minimum of 2 years of related experience.

Salary : $60,000 - $80,000