We are seeking a Site/Operations Head, reporting to the COO.
The Site Operations Head will direct all facets of Operations in a biopharmaceutical manufacturing facility. He/She is accountable for achieving business objectives that ensure that work schedules are adhered to, costs are contained, and high-quality work is performed in a manner that is compliant with government regulations.
The Site Operations Head partners with the CEO, COO & CFO to develop operational strategies and practices, to ensure compliance to Vibalogic’s quality standards and performance of the operations to meet goals
The Site Operations Head will provide the leadership, management and vision necessary to ensure that the company has the proper controls, administrative and reporting procedures, and people systems in place within Laboratory and Manufacturing Operations. This position is responsible for meeting cGMP compliance standards and ensuring that Vibalogics meets the planning and production needs of our customers, with the appropriate systems and equipment. The Site Operations Head will represent Vibalogics during audits and customer visits.
Oversees Manufacturing, Facilities, Maintenance, Supply Chain, & EHS.
Essential job functions:
- Hire, recruit, coach, and ensure appropriate provision of training for employees within all areas of operations.
- Lead operations to ensure departmental commitments and deliverables are achieved to meet company objectives
- Oversee the planning, scheduling, and production functions to ensure that adequate materials, equipment, and personnel are available to meet production schedule.
- Interface with clients and regulatory individuals
- Encourage and enforce a culture of proactive surveillance and compliance regarding Safety, Environmental, Quality standards as required by cGMPs, Health Authority regulations, government agencies, and company standards / policies. Support all site audits and inspections.
- Ensure that the plant environmental monitoring systems are properly maintained and operating to provide an environment acceptable for cGMP quality production and that the systems and equipment are tested and calibrated as scheduled
- Ensure adequate resources are dedicated to correcting important or critical issues via personal involvement, delegated resources, and/or appropriate escalation
- Lead departmental and site teams to solve problems, initiate improvements, establish procedures, transfer new products or technologies, execute projects, etc.
- Provide high-quality forecasts and consistently meet financial commitments within areas of direct management responsibility. Proactively identify and communicate areas for operational and financial improvement within the function and the company
- Maintain a high-performing organization. Hire, train, develop, and evaluate talent and effectively implement the company’s performance management practices. Establish departmental and individual expectations; provide direction and balanced performance feedback; coach, develop, and challenge direct reports; enforce company policies; and deal with personnel issues promptly
- Maintain open communication via one-on-one and team meetings
- Make decisions, based on the professional judgment, experience, budget, and the ethical guidelines of good business practices
- Effectively lead site managers within Operations, Supply Chain, Engineering, Facilities, and EHS in the setting of objectives and the generation of relevant measures in support of those site objectives
- Work closely with the Process Development teams in the generation and approval of proposals
Knowledge, skills and experience:
- Bachelors/Masters degree in Biology, Biochemistry, Chemistry, or other appropriate field
- Minimum of 10+ years hands on experience in biotechnology/pharmaceutical manufacturing practices, guidelines, management practices, cGMP knowledge, and production and planning operations
- 8 years or more in an Operations Leadership role
- Disciplined individual with excellent attention to detail who is able to challenge the status quo successfully from within a team
- Proven business acumen with bottom-line orientation
- Demonstrated experience supporting continuous improvement around Safety Quality Delivery and Cost (SQDC) using a methodology such as LEAN and/or Six Sigma
- Manufacturing Information Systems know-how and experience in a high growth setting
- Ability to work by influencing peers and their reports and gain their cooperation
- Ability to see the “big picture” while being capable of driving detailed, tactical execution. A high sense of urgency and a commitment to delivering results is essential
- Strong people management and organizational skills; ability to prioritize and manage through complex processes/projects
- Strong interpersonal and communication skills, verbal and written
- Proven Management and Leadership skills
- The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions
- While performing the duties of this job, the employee is frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms; and talk or hear. The employee is occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, and ability to adjust focus
- In the performance of the duties of this job the employee is required to travel up to 25% of the time, including internationally
- A flexible work schedule is required
- This role will be based in Boxborough, MA
Vibalogics US, Inc. offers a very competitive benefits package including medical, dental, vision, prescription drug coverage, life and disability insurance, 401(k), and generous vacation and time off policies among other attractive benefits. We operate in a world class facility to attract the best and brightest talent to work collaboratively in our mission to bring novel therapies to the patients who need them most.
To Apply: please forward a resume to: Linda.firstname.lastname@example.org
Vibalogics, Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age status as a qualified individual with a disability, protected veteran status, or any other characteristic protected by law.