Manager, Metrology Lab Support

Description

Tris Pharma, Inc. (www.trispharma.com) is a leading privately-owned U.S. biopharmaceutical company with a focus on development and commercialization of innovative medicines in ADHD, spectrum disorders, anxiety, pain and addiction addressing unmet patient needs. We have >150 US and International patents and market several branded ADHD products in the U.S. We also license our products in the US and ex-US markets. We have a robust pipeline of innovative products spanning neuroscience and other therapeutic categories employing our proprietary science and technology.

Our science and technology make us unique, but our team members set us apart; they are the engine fueling Tris' passion and innovation. Our colleagues understand the criticality of operating a successful business and take pride in the company's success. Equally importance to each team member is how we interact with one another on a daily basis. We believe in each other and in respectful, open and honest communications to help support individual and team success.

Our Metrology Department, located in our Monmouth Junction, NJ headquarters has an immediate need for a Manager, Metrology Lab Support.

Summary

The Manager, Metrology Lab Support establishes and maintains a calibration and preventive maintenance (PM) program for company's current Good Manufacturing Practices (cGMPs) laboratories ensuring compliance following analytical methods, United States Pharmacopeia (USP)/National Formulary (NF) Chapters, protocols, Standard Operating Procedures (SOPs) under cGMPs and company policies. The incumbent, working closely with external vendors, laboratory management and Quality Assurance (QA) department, coordinates and oversees the timely, accurate and compliant execution of calibration activities and qualification.

The incumbent also handles managerial functions/initiatives including, but not limited to: interviewing and training Metrology staff; overseeing work flow and scheduling and directing work; serving as technical resource and department leader; problem solving as needed to meet the demands of quality and production, etc.

ESSENTIAL FUNCTIONS

Primary duties/responsibilities

• Ensures compliance with all cGMP, Food and Drug Administration (FDA), Drug Enforcement Agency (DEA), and Occupational Safety and Health Administration (OSHA) regulations, as well as all applicable company compliance guidelines, standards and objectives; Provides supervision and mentorship to Metrologists and support staff; Oversees all Metrology functions and serves as technical resource and team leader within the group while managing day to day functions, problem solving as needed to meet the demands of quality and production, supporting and coordinating tasks and assuring completion, coordinate training of new or current employees as needed
• Oversees routine calibration and instrument performance verification, maintenance and repairs on highly complicated instrumentation such as: High Pressure Liquid Chromatography/Ultra Performance Liquid Chromatography (HPLC/UPLC), Gas Chromatography (GC), ultra-violet visible spectrophotometry (UV-Vis), Fourier Transform Infrared (FTIR), Muffle Furnace, Viscometers, Density Meters, Melting Point, Dissolution and Autosampler, Polarimeter etc.
• Supervises and maintains laboratory calibration and PM programs to ensure compliance with applicable regulations; Guides and supports troubleshooting, testing, repair and optimization activities for lab instrumentation, equipment and control systems; Coordinates with laboratory management to support Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) of new or modified products/processes and relocation activities
• Maintains and coordinates vendor contracts/agreements pertaining to calibration to ensure quality system requirements
• Creates, reviews and revises metrology and calibration policies and SOPs, as needed; Leads or participates in instrument related investigations; Supervises and supports the change control and corrective actions, preventive action (CAPAs) process related to analytical instrumentation , as needed
• Oversees QC and contract laboratory receipt and reporting of purified water sampling; Manages and oversees disposal of laboratory sample waste and solvent waste per established safety procedure and Drug Enforcement Administration (DEA) procedure; Handles and maintains laboratory supply inventory (i.e., materials, reagents, glassware, etc.) and storage
• Actively participates and assists with internal and external audits including Food and Drug Administration (FDA) for all cGMP laboratory analytical instrumentation
• Manages, coaches and mentors direct reports

Requirements

Requirements

KNOWLEDGE/SKILLS/ABILITIES REQUIRED

Minimum education and years of relevant work experience

Bachelors degree in Chemistry or related science field and minimum 8 years experience in pharmaceutical or biotechnology industry working in Metrology, Method Validation (MV), Quality Control (QC) and/or related laboratories in positions of increasing technical and supervisory responsibility.

Special knowledge or skills needed and/or licenses or certificates required

• Experience working with Food and Drug Administration (FDA), current Good Laboratory Practices (cGLPs), cGMPs, SOPs and regulatory rules, regulations and guidelines
• Strong working knowledge and hands-on experience performing routine metrology, calibration, maintenance and/or troubleshooting of analytical instrumentation (i.e., HPLC/UPLC, GC, Dissolution Apparatus and Autosamplers, UV-Vis, Density Meter, Balances, Ovens, Viscometers, Melting Point apparatus, Refractometer, Polarimeter, Media Dispenser Ezfill, etc.)
• Proficiency with Microsoft Office
• Excellent verbal and written communication and skills
• Ability to work independently and collaboratively, as required, in a fast paced, matrixed, team environment consisting of internal and external team members
• Analytical thinking with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines
• Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects
• Fluent in English (verbal and written)
• Ability to identify and distinguish colors
• Ability and willingness to work additional hours required by business needs

Special knowledge or skills needed and/or licenses or certificates preferred

People management experience

Travel requirements

0%

Physical requirements

Laboratory based position

Anticipated salary range: $120k - $140k annually

Base salary offered is contingent on assessment of candidate's education and experience level relative to requirements of the position and a review of related industry standards and internal equity.

Additional benefits: In addition to base salary, full-time employees are also eligible for incentives, including, but not limited to: bonus eligible, medical, dental, vision, Rx insurance, 401K with match, life insurance, paid Company Holidays, PTO, Paid Volunteer Time and Employee Resource Groups.

Tris Pharma, Inc. offers a highly competitive compensation and benefits package. To build and enhance our diverse workforce, we encourage applications from individuals with disabilities, minorities, veterans, women, LGBTQ, etc. Tris Pharma, Inc. is an Equal Opportunity Employer. #LI-_