Supervisor, Packaging at Tris Pharma

South Brunswick, New Jersey, United States -

Full Time

Start Date

Immediate

Expiry Date

03 Jun, 26

Salary

85000.0

Posted On

05 Mar, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

cGMP Compliance, FDA Standards, SOP Development, Personnel Training, Workflow Oversight, Scheduling, Problem Solving, Quality Assurance, Production Management, Material Management, Auditing, Deviation Investigation, Equipment Knowledge, Record Keeping, Microsoft Office Proficiency, Analytical Thinking

Industry

Pharmaceutical Manufacturing

Description

Description Tris Pharma, Inc. (www.trispharma.com) is a leading privately-owned biopharmaceutical company in the U.S. with a focus on development and commercialization of innovative medicines that address unmet patient needs. We have more than 150 US and International patents including applications and have marketed several branded and generic products in the U.S., have licensed our products in the US and international markets, and 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 it is our team members that set us apart; they are the engine that fuels Tris’ passion and innovation. Tris colleagues understand the criticality of operating a successful business and take pride in the company’s success. But of equal importance to each member of the team is how we interact with one another on a daily basis. We believe in each other, and we believe in respectful, open and honest communications to help support individual and team success. Located in Monmouth Junction, New Jersey, Tris Pharma has an immediate opening for a Packaging Supervisor on 2nd shift. Hours are 3:00 PM – 1:00 AM DESCRIPTION: The Supervisor, Packaging overseas and coordinates all aspects of packaging for new or existing products. She/he is responsible for the day-to-day production, safety, scheduling, staffing, material management, compliance, training and auditing activities in order to meet customer requirements including deadlines and quality in accordance with Standard Operating Procedures (SOPs), current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA) standards and batch record specifications. Collaborating and working closely with Packaging leadership, the incumbent performs many Packaging supervisory functions/initiatives including, but not limited to interviewing and training Packaging personnel, overseeing workflow and scheduling, directing work, serving as technical resource and department leader, problem solving as needed to meet the demands of quality and production, etc ESSENTIAL FUNCTIONS: · Assures compliance with all applicable local, state and federal regulations, regulatory agency requirements including, but not limited to: cGMP, FDA, etc. as well as all applicable company compliance guidelines, standards and objectives · Provides supervision and mentorship to Packaging personnel; Oversees all functions of Packaging daily responsibilities; 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 Packaging personnel, as needed · Ensures all department functions are completed according to the agreed timeline and data documented in accordance with internal requirements and cGMP regulations; Assists in resolving issues, tracking quality trends, recommending plans to improve quality and productivity · Works collectively with the other Supervisors to organize the daily schedule and assigns personnel to various workspaces to meet planning demand; Provides guidance, support and direction through positive interactions with manufacturing associates during daily operations · Reports and investigates any deviations from processes or procedures · Maintains a presence on the production floor at all times; Trains new employees and mentors lower level technicians as appropriate · Assists with the development and writing of SOPs and investigation reports and contributes to the circulation of the documents under approved procedures · Possesses total comprehension and working knowledge of the packaging equipment and packaging processes in designated areas · Maintains safe and clean work environment by educating and directing personnel on the use of all control points, equipment, and resources; Maintains compliance with established policies and procedures · Issues work orders, as needed Requirements QUALIFICATIONS REQUIRED Minimum education and years of relevant work experience High School diploma or equivalent AND minimum 10 years related work experience OR Associates degree and 7 years related work experience OR Bachelor’s degree and minimum 5 years related work experience. Related work experience must include multiple aspects of the packaging and/or manufacturing process in a pharmaceutical or biotechnology cGMP regulated environment. Full understanding and knowledge of packaging equipment and the operations of packaging equipment. Special knowledge or skills needed and/or licenses or certificates required · In depth working knowledge of manufacturing procedures and federal regulations pertaining to manufacturing processes · In depth working knowledge of good manufacturing and packaging systems and familiarity with regulatory and manufacturing SOPs and cGMPs · Demonstrated ability to read and interpret documents such as safety and environmental policies, operating and maintenance instructions and procedure manuals, etc. · Strong record keeping skills · Prior pharmaceutical packaging group lead or supervisory experience · Ability to train, motivate, direct and supervise packaging personnel · Proficiency with Microsoft Office · 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 problem-solving skills and the ability to adapt to changing priorities and deadlines · Planning, organization and time management skills including the ability to support and prioritize multiple projects · Fluent in English (verbal and written) · Ability and willingness to work additional hours as required by business needs Special knowledge or skills needed and/or licenses or certificates preferred Hands on experience with multiple packaging forms Travel requirements 0% Physical requirements Manufacturing based position Ability to lift up to 50 lbs Ability to use Personal Protective Equipment (PPE) Ability to stand for extended periods Anticipated salary range: $80,000 to $85,000/yr. Plus shift differential. 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.

Responsibilities

The Packaging Supervisor oversees and coordinates all packaging aspects for new or existing products, managing daily production, safety, scheduling, staffing, material management, compliance, training, and auditing to meet quality and deadline requirements. This role involves close collaboration with leadership to perform supervisory functions such as interviewing, training personnel, overseeing workflow, directing work, and serving as a technical resource to solve production and quality issues.