Manager, Operations

Work Schedule Standard (Mon-Fri) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

GROUP/DIVISION SUMMARY

The Drug Product Division - North America (DPD-NA) is one of the five divisions that make up the Pharma Services Group. We are made up of approximately 4400 colleagues across six sites who specialize in taking sterile injectable and oral solid dose drug products from development to commercialization.

POSITION SUMMARY

The Operations Manager leads administratively and technically the compounding/dispensing/filling operations of the Sterile Production Operations. Ensure established GMP's and all other requirements of Thermo Fisher Scientific and Quality systems are met. Coordinates and schedules filling activities and budgeted production volumes and goals are met. Ensures appropriate training standards for the operations are established and personnel is trained appropriately. Ensures the lowest possible cost of goods in compliance with existing rules and regulatory requirements.

Key Responsibilities:

• This position is responsible for the day to day operation of one Sterile manufacturing and filling lines including three Freeze Dryers. Tasks include maintaining compliance status of area, assuring schedules are established/maintained and perform ethnical oversight to ongoing operations and troubleshooting.
• Lead filling operations by directing the production activities daily. Ensures scheduled activities are performed as planned.
• Ensure GMP compliance and meets requirements of Thermo Fisher quality systems.
• Ensure production efficiencies are monitored and action taken to lower variable standard costs.
• Manage the administrative aspects of the group by ensuring the preparation of performance plans, job descriptions, and conducting employee performance reviews. This also includes hiring, rewarding, and disciplining staff as required; providing direction for professional development; maintaining an environment that fosters teamwork; and assigning responsibility and accountability at proper levels.
• Prepare expense and headcount budgets. Ensure budget targets are met while providing production operations with adequate resources to meet customer demands.
• Support the company’s safety program to improve safety awareness and provide a safe work environment.
• Manage filling operations by directing the production activities daily. Ensures scheduled activities are performed as planned.
• Comply with all job-related safety and other training requirements.
• Technical and operational knowledge of Aseptic processing operations demands ability associated with balancing multiple ongoing activities corresponding prioritization of tasks. The position is the key interaction with customers in the commercial operation of the described lines. Position must also be capable of handling customer and regulatory interactions

Qualifications:

• Bachelor’s degree in Science in Engineering, Operations Management or related field is required. Equivalent combinations of education, training, and relevant work experience may be considered.
• 6+ years of pharmaceutical operations or quality experience and at least 2+ years in a significant management role is required. Experience in a large Pharma company in product development would be preferred.
• Technical and operational knowledge in pharmaceutical or medical devices environment, preferable.
• Attention to detail and organizational skills. Self-starter, mature, independent and dependable
• Ability to work in a fast-paced environment under pressure
• Able to identify and implement process improvement initiatives to reduce cost and increase efficiencies in the operations.
• Effective time management and prioritization skills.
• Effective and strategical verbal/written communication skills at all levels.
• High level of social skills to establish and maintain effective working relationships with employees and the customers; including tact to handle critical matters
• Ability to motivate, energize, and retain key staff by direct interactions with supervisors and staff.
• Ability to handle and lead professional staff in order to achieve goals, evaluate and resolve complex technical problems
• Ability to delegate tasks to a group of people

Physical Requirements:

Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time.