Manufacturing Ops Support Specialist I/II/III - Commercial

The field of gene therapy is growing rapidly and Genezen is here to meet the exacting needs of our clients. We provide process development, produce GMP viral vectors, and provide cell transduction for gene and cell therapy clinical trials and are proud to be a part of the process that leads to new cures.

WORKING AT GENEZEN

Many people have worked in environments where you feel like just another nameless part of an enormous machine. Genezen is different. We want our employees to be innovative, collaborative problem solvers who are dedicated to meeting the challenges of working at a fast-growing company. We are dedicated to empowering our employees to be their best and making Genezen a rewarding place to work. Every employee contributes to the success of the company and you can be part of that team.

JOB SUMMARY

The Manufacturing Operations Support Specialist - Commercial will be part of a cohesive team responsible for Deviation investigations, CAPAs, and Change Controls for all phases of manufacturing. The Manufacturing Specialist uses expert knowledge of cGMP regulations and project management to ensure manufacturing readiness and compliance. The incumbent will also support equipment, documentation and process operations improvement initiatives within Manufacturing. The Specialist works independently with minimal supervision and direction. Performs work that consistently requires independent decision making and the exercise of independent judgment and discretion.

This position is located in Lexington, MA. The level of this position will be determined based on the selected candidate's qualifications, skills, and relevant experience

ESSENTIAL JOB FUNCTIONS

Practices and promotes safe work habits and adheres to safety procedures and guidelines

Utilizes manufacturing process knowledge and investigation skill to identify and resolve manufacturing issues, improve process operations and affect positive change.

Performs root cause analysis on Manufacturing quality events and leads investigations for minor and major quality events.

Identifies and drives Manufacturing corrective and/or preventative actions.

Provide Manufacturing support for tech transfers

Attend Change Control Review Meetings to present and resolve questions related to changes. Prepare assessments on changes impacting manufacturing.

Participates on cross functional teams to drive complex manufacturing operations changes or improvements

Supports document revisions and/or document management including batch production records and manufacturing procedures

Performs training with staff on the floor

Provides expertise for processing technology (chromatography, filtrations, digital systems, etc…)

Participates in cross-functional equipment and operational process improvement while teaming with Engineering, Validation, Quality Assurance, Quality Control, Facilities, and Manufacturing Science and Technology

Lead by example by demonstrating current good manufacturing practices, complying with standard operating procedures, and maintaining compliant manufacturing documentation.

Performs work that consistently requires independent decision making and the exercise of independent judgment and discretion, with periodic management guidance

Reviews the work of others and provides feedback

Creates and presents trending and metrics reports

Participates in equipment start-up, commissioning, and validation activities

Works in a manner that requires consistent exercise of discretion and judgment

SPECIAL JOB REQUIREMENTS

Adaptability required as work schedule may change based on business needs

Criminal background check required

Other duties as assigned

KNOWLEDGE, SKILLS AND EXPERIENCE

EDUCATION / CERTIFICATIONS / LICENSES

Essential/Desired

BS or MS degree in biology, biochemistry, molecular biology, or related field, or equivalent experience

Essential

ON-THE-JOB EXPERIENCE

Minimum 1-8+ years related industry experience in related field

Essential

Experience with owning, investigation and writing deviations, creating and executing CAPAs, and writing and managing Change controls

Essential

Experience in biomanufacturing unit operations (USP and/or DSP)

Essential

Experience performing root cause analysis using practices, such as Event & Causal Factor Charting, Kepner-Tregoe Problem Analysis, and the basic Quality Improvement Tools (e.g., Pareto Chart, Control Chart, and Process Map, etc.)

Essential

Able to adhere to company internal and regulatory (EMA, FDA) policies, processes and procedures

Essential

SKILLS / ABILITIES

Ability to apply systems thinking as part of a problem-solving

Essential

Demonstrates industrial empathy when working with stakeholders

Essential

Detail oriented and able to self-organize

Essential

Able to communicate in a professional way on diverse levels and channels

Essential

Takes the initiative to own and resolve issues

Essential

Good technical writing and oral communication skills

Essential

COMPENSATION

This position may be filled at either the Specialist I, II or III level, depending on the qualifications and experience of the selected candidate. The anticipated annual salary range is: $65,000-$105,000. Actual hourly rate and level will be determined based on relevant experience, skills and education.

PHYSICAL DEMANDS

While performing the duties of this job, the employee is required to meet the following physical demands:

Work Environment

Frequently required to work in a GMP clean room environment with personal protective equipment/aseptic gowning

Regularly required to work around equipment and typical utilities seen in pharmaceutical facilities

Occasionally exposed to moving mechanical parts; high, precarious places; toxic or caustic chemicals; hazardous waste; and risk of electrical shock

Occasionally exposed to loud noise levels

Spending time on the floor during activity execution is required

Movement

Frequently required to stand; sit; walk; balance; stoop; kneel; crouch; use hands to finger, handle, or feel; reach with hands and arms

Occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl

Lifting

Frequently lift and/or move up to 25 pounds

Occasionally lift and/or move up to 40 pounds

Vision

• •Frequently utilize close vision and the ability to adjust focus
• Communication

Frequently required to communicate by talking, hearing, using telephone and e-mail

GENEZEN'S CURES VALUE-BASED COMPETENCIES

• C ommitted to Science
• We are committed to scientific excellence, staying current with industry developments, making data-driven decisions, and pursuing innovation to advance healthcare.

• U rgency in action for the patients
• We operate with urgency and a commitment to delivering timely treatments to patients by accelerating our partners' programs.

• R esilience & Grit in operations
• We are committed to overcoming challenges, learning from failures, and persistently striving for success.

• E xecute with Excellence & Integrity
• We are dedicated to delivering quality results and upholding ethical principals.

• S olutions driven for our partners
• We are committed to being a proactive, collaborative, creative and open-minded partner.

GENEZEN'S BENEFITS

Paid vacation days, amount based on tenure

Paid sick time

10 observed holidays + 2 floating holiday + 1 volunteer day

401(k) plan with company match up to 6% of salary

Share Appreciation Rights

Choice of several healthcare plans

FSA and HSA programs

Dental & vision care

Employer-paid basic term life/personal accident insurance

Voluntary disability, universal life/personal accident insurance

Accidental Death & Dismemberment (AD&D) Insurance

ADDITIONAL DETAILS

Nothing in the job description for this role restricts management’s right to assign or reassign duties and responsibilities to this job at any time.

This position requires a criminal backgr