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 Planning and Scheduling Manager role is integral to the on-time delivery of compliant materials for Operations. This role supports day-to-day materials management by working with internal stakeholders and managing external relationships. These activities are performed in accordance with cGMP guidelines and departmental and inter-departmental policies and standard operating procedures. The Planning and Scheduling Manager will lead and develop a team of Supply Chain Specialists, operating efficiently to ensure material availability while reducing inventory costs.
ESSENTIAL JOB FUNCTIONS
- Provide leadership, coaching, and mentoring to the Supply Chain organization, managing a team of Supply Chain Specialists.
- Manage material planning and scheduling activities for Manufacturing and PD/AD, facilitating collaboration with Facilities to provide site schedule.
- Collaborate with external customers to assess material and scheduling requirements to meet project timelines.
- Manage distribution requirements for all clinical and commercial supplies.
- Responsible for maintenance of MRP, Production Orders, and BOM master data in Enterprise Resource Planning system.
- Develop comprehensive demand supply planning and scenario planning model for managing supply chain programs
- Drive the long-range capacity planning process in alignment with Genezen’s corporate, financial, and client pipeline launch plans utilizing inputs from Business Development, external clients, and internal manufacturing, to understand capacity constraints, supplier risk, COGS, expansion/optimization options and related costs/timelines.
- Document and present long-range plan, supply risks, cost, and delivery metrics in S&OP governance meeting to enable supply assurance, risk management, quality performance, and cost efficiency.
- Work collaboratively and effectively with cross-functional teams including but not limited to Finance, Manufacturing, Quality Assurance, Quality Control, PD/AD, Procurement and Warehouse to identify and execute process improvement opportunities.
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
- BS/MS degree in business or related field (e.g., Business Management, Supply Chain, or Finance)
- APICS Certification (preferred)
- 5-10 years of relevant GMP experience in pharma/biotech company, working within a quality system and regulated GMP environment
- 2+ years of management experience
- Well versed in cGMP/ICH/FDA/EU regulations and guidelines
- 5+ years experience working with ERP systems
- Strong people leadership and development qualities
- Excellent computer, verbal, and written communication skills
- Ability to work independently with minimal supervision, as well as working effectively as part of a team
- Ability to adapt quickly to change, such as but not limited to ideas, responsibilities, and strategies
- Analytical problem solving
PHYSICAL DEMANDS
While performing the duties of this job, the employee is required to meet the following physical demands:Work Environment
- Regularly sit for long periods of time
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 10 pounds
- Occasionally lift and/or move up to 25 pounds
Vision
- Frequently utilize close vision and the ability to adjust focusCommunication
Communication
- Frequently required to communicate by talking, hearing, using telephone and e-mail
GENEZEN'S CURES VALUE-BASED COMPETENCIES
Committed to ScienceWe are committed to scientific excellence, staying current with industry developments, making data-driven decisions, and pursuing innovation to advance healthcare.Urgency in action for the patientsWe operate with urgency and a commitment to delivering timely treatments to patients by accelerating our partners' programs.Resilience & Grit in operationsWe are committed to overcoming challenges, learning from failures, and persistently striving for success. Execute with Excellence & IntegrityWe are dedicated to delivering quality results and upholding ethical principals.Solutions driven for our partnersWe 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, vested immediately
- 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 background check.
- Genezen is an Equal Opportunity Employer.
- Genezen participates in EVerify.
- Genezen is interested in every qualified candidate who is eligible to work in the United States; however, we are not able to sponsor visas.
Genezen has operates two locations: one in Fishers, Indiana and the second in Lexington, Massachusetts. Fishers is a suburb of Indianapolis. Fishers was named the #1 place to live in the US by Money Magazine in 2017 for its livability, safety and entrepreneurship. Fishers is one of the fastest growing communities in Indiana and is dedicated to supporting a high quality of life for all its residents. Nearby Indianapolis is home to professional and college sports teams, the Indy 500, a growing art community and the world’s largest children’s museum--to name just a few reasons why this area is a great place to live.Lexington, Massachusetts, located just northwest of Boston, is renowned as a historic suburb with a rich cultural heritage.
It boasts picturesque New England charm, tree-lined streets, and a vibrant community. Known for its pivotal role in the American Revolution, Lexington offers visitors and residents alike a blend of historical landmarks, modern amenities, and a strong sense of community pride.
