Site Operations Head - Boxborough
Arranta Bio is a rapidly growing and dynamic bio-pharmaceutical contract development and manufacturing organization (CDMO). Our vision is to be the best in class CDMO providing development and GMP manufacturing services to microbiome innovators within the pharmaceutical industry. Therapies focused on the human microbiome are exhibiting incredible potential towards revolutionizing disease etiology and associated medical treatments. Arranta Bio’s mission is to build a world class organization which provides microbiome bio-pharmaceutical innovators with a single source of supply from early process development through clinical and commercial GMP finished product.
WHO ARE WE
Arranta hires people who are committed and passionate to the goal of bringing life enhancing products to patients. We want top talent who will render ideas and a relentless desire towards accomplishing our mission; when a job becomes a passion, it makes you feel ALIVE.
Here at Arranta Bio, we embrace ALIVE – our core values that we live and breathe daily! We are Agile, Leading, Innovating, Value Creating, and Engaging.
We embrace our challenges as opportunities.
We are empowered to think and act.
We never settle; we strive to improve through purposeful creativity.
We build aligned teams who learn, grow, and deliver.
We are committed to building strong relationships.
Are you ready to come ALIVE with a daring and intrepid team? Don’t wait another minute; Apply today!
The Site Operations Head will direct all facets of Operations in a biopharmaceutical manufacturing facility. They are 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 SVP of Site Operation, CEO, COO& CFO to develop operational strategies and practices, to ensure compliance to Arranta’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 Arranta Bio meets the planning and production needs of our customers, with the appropriate systems and equipment. The Site Operations Head will represent Arranta during audits and customer visits
ESSENTIAL JOB FUNCTIONS
- 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 meets financial commitments within areas of direct management responsibility. Proactively identify and communicate areas for operational and financial improvement within the function and the company.
- 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.
- 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.
- Other duties as assigned
Experience and Skills
- Bachelors/Master’s degree in Biology, Biochemistry, Chemistry, or another appropriate field.
- Minimum of 10+ years hands on experience in biotechnology/pharmaceutical manufacturing practices, guidelines, management practices, cGMP knowledge, and production and planning operations.
- 10+ years in an Operations Leadership role.
- 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.
- Proven Management and Leadership skills
- Disciplined individual with excellent attention to detail who is able to challenge the status quo successfully from within a team.
- 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
- 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 occasionally, drive a motor vehicle.
- Communicate using telephone and e-mail.
- Phone reimbursement policy for qualified individuals
- Free parking
- Highly competitive healthcare with many plan options:
- Medical (HMO/PPO/EPO)
- Flexible Spending Accounts for medical expenses and dependent care expenses
- Up to 10 weeks of 100% paid maternity leave
- 2 weeks of 100% paid paternity, domestic partner, & adoption leave
- Educational assistance program
- 401k (traditional and Roth offered) with 100% match on first 5% deferred.
- A suite of Arranta Bio paid insurance coverage, including life insurance, short-term and long-term disability
- Voluntary legal assistance plan
- Employee Referral program
- Competitive PTO plan, in addition to 10 company paid holidays (includes 2 floating holidays)