Description

Position Summary: 

• Supervise the day-to-day technical operations and quality of the R&D Chemistry laboratory in a high-growth, fast-paced, dynamic work environment while ensuring compliance with FDA cGMP/GLP and DEA regulations.

• Supervise technical support to clients and company groups related to R&D, method development, validation and tech transfer for both in-house and outsourced work.

• Plans, organizes, and supervises resources on R&D projects to assure technical and regulatory quality, budget and schedule adherence.

• Complete laboratory notebook reviews and prepare/review summary reports. 

• Assists with additional work duties or responsibilities as evident or required.

Requirements

Primary Accountabilities: 

• Supervises the R&D technical functions of the chemistry lab to ensure cGMP compliance. Works independently to supervise day to day activities for all R&D method development, validation and verification analysis.

• Oversees analytical techniques, interpretations of analytical data, problem solving and troubleshooting as required for R&D approval.

• Prepare SOPs, guidance, protocols, reports, to support laboratory GMP function in compliance with FDA, ICH and other regulatory guidance.

• Provide leadership, monitor scientists within the group.

• Communicate with direct reports (as applicable), management team, internal and external customers about project and business-related matter.

• Ensures CMC strategy of drug development and regulatory guidelines are followed.

• Designs and performs or supervises, in accordance with USP and ICH guidelines, the analytical method development, validations/verifications and method transfer activities, stability and release testing with both internal and external partners.

• Capable of working with different analytical techniques including but not limited to HPLC, LC-MS, GC, Automatic Titrator, IR, DSC, ICP, and Mass Spectrometry.

• Use project management techniques to identify, develop and maintain planning tools (e.g., spreadsheets, MS Project) in support of R&D projects.

• Participates in the development and implementation of associated programs (e.g. cleaning validation, production component leachable/extractable, process validation, GMP compliance, equipment validation, maintenance and use, etc.)

NOTE: The primary accountabilities and the knowledge, skills and abilities listed below, are intended to describe the general content of and requirements for this position and are not intended to be an exhaustive statement of duties. Incumbents may perform all or most of the primary accountabilities listed. Specific tasks or responsibilities will be documented in the incumbents’ performance objectives as outlined by the incumbents’ immediate supervisor or manager.

Knowledge, Skills & Abilities: 

• BSc, MSc, PhD in Biochemistry, Chemistry or a related science degree.

• Min of 2 years in a management or supervisory role in a regulated cGMP/GLP analytical laboratory or related area.

• Method development validation experience gained in an R&D environment.

• Strong leader, able to interview, hire, train and mentor new staff.

• Strong knowledge of FDA manufacturing/regulatory quality systems regulations, qualification, facilities and investigation requirements.

• It is expected that the incumbent will have skills in HPLC, GC, and mass spectroscopy detection technologies. Familiarity with cGMP and regulatory guidance is also required. Excellent communication and technical writing skills are essential in order that this person can effectively work with multiple teams simultaneously in a highly matrixed environment. The colleague is expected to be a leader in the technology area and to train others for more routine and specific project-oriented applications.

• The ability and willingness to change direction and focus to meet shifting organizational and business demands.

• The ability to effectively manage one self, demonstrates integrity, be productive under pressure, and achieve development goals.

• The ability to supervise a multitude of resources and to be accurate and current with data and information.

• The ability to create new products and processes that add value to the Business, by generating new ideas and applying creative and analytical approaches.

• Must possess direct experience in analytical method development, transfer and validation.

• The ability and willingness to change direction and focus to meet shifting organizational and business demands.

• Must strive for continuous improvement in all work activities.

• The ability to take strategic objectives and accept accountability, motivate and influence others thinks globally and leverages diversity.

• Position requires typing, climbing, lifting (up to 151bs), reaching, vision (20/20), standing (10%), sitting (90%), walking, and hearing.

• Additional Requirements: As needed

• Salary range: Based on experience