The Specialist role is accountable for the oversight and execution of support activities within the Marek’s Production Teams. They are responsible for supporting the key Quality and Safety Compliance KPIs and will act as Lead/SME for critical systems, deviations, projects, and product transfer deliverables for the team. They will also provide support for the coaching, development, and SME training of employees within the team.

Employee Development & Leadership:

• Models Company leadership principles and inclusive behaviors.

• Acts as a Subject Matter Expert (SME) to support coaching and skills development within the Focus Factory.

• Acts as a Subject Matter Expert (SME) for the delivery of training material specific to their assigned responsibilities.

Safety Compliance:

• Demonstrates a strong compliance mindset (EHS, Quality, and Finance) and continuously sets a high standard for themselves and their team.

• Follows safe operating instructions for all tasks and equipment.

• Accountable for Operations Biosafety support, including representation on the Biosafety Committee, and conducting BAR reviews.

• To follow up on any reported defects or workplace hazards immediately.

• To report all accidents, incidents, and near misses within 24 hours and to participate in the investigation and identification of effective corrective and preventative actions.

• Responsible for safety event management and root cause investigation.

Quality Compliance:

• Is accountable for the on-time completion of Quality compliance tasks in relation to Deviation, CAPA, and Change Control management.

• Is accountable for all aspects of Quality Assurance including cGMP, RFT, and good documentation practices, and provides coaching to the Operations teams.

• Serves as Change Manager and Stakeholder for change management activities within Production.

• Is accountable for the update, review, and approval of GMP documentation including, but not limited to:

• Represents Production in the support of Seed Management activities.

• Acts as a Subject Matter Expert (SME) for the completion of Annual Outline Reviews (AOR).

Productivity:

• Supports the weekly and monthly schedule adherence of production activities within their department.

• Accountable for creating a culture of continuous improvement and leading by example.

• Accountable for the execution of effective problem-solving within Production and ensuring that outcomes are shared appropriately.

• Is accountable for monitoring yield trends within Production and initiating appropriate actions in response to deviation from defined limits.

• Is responsible for the discard process, including trending and the initiation of corrective actions.

Financial:

• Supports departmental budget for Spend, Production Activity, and Discards.

• Recognizes and investigates opportunities for financial savings.

• Is accountable for managing Production purchasing activities such as managing POs and new vendor requests.

• Shape solutions out of complexity - Is open and curious about others’ perspectives. Organized analytical thinker with a high level of energy

• Client focus - Has in mind the client’s satisfaction

• Collaborate with empathy - Has a positive attitude toward collaboration

• Engage and develop – Clarifies short-term directions. Demonstrates continuous leadership ability and qualities.

• Drive ambition and accountability - Proactively manages own and others’ work. Self-motivated and can work with minimal supervision

• Influence others - Communicates transparently

• Education - Bachelor's degree in a scientific field (i.e. chemistry, general biology, cellular biology, microbial biology, etc.) or at least 4 years of experience in a related field

• Work Experience – Minimum of four years experience in the biologics industry; two or more years of manufacturing support experience in the biologic/pharma industry preferred.

• Other (consider certifications, specialized knowledge and/or training, etc.) - Knowledge of Quality Systems; investigations/CAPAs/ performing gap assessments

• Technical writing experience preferred.

• Lean, Six Sigma experience preferred.

• Continuous improvement project experience preferred.

• Able to read, write legibly, and communicate in English

• Dexterity: Frequent fine motor movement

• Lifting 50lbs

• Daily dressing and operating in clean room required garments and PPE

• Cleanroom manufacturing environment

• Ability to work flexible and sometimes extended hours

• N/A

This job description is intended to convey information essential to understanding the scope of the job and the general nature and level of work performed by job holders within this job.This job description is not intended to be an exhaustive list of qualifications, skills, duties, responsibilities, or working conditions associated with the job.This job description is not an employment contract.Ceva reserves the right to modify job duties and/or job descriptions at any time to meet the needs of the business.