Immediate opportunity for a Specialist Manufacturing, New Product Introduction. In this critical role, you will lead the introduction of new pharmaceutical products into the manufacturing plant in Thousand Oaks, CA.
As a New Product Introduction (NPI) Lead, you will be responsible for cross-functional project management, change control ownership, and timeline execution to deliver clinical and commercial products into manufacturing right-first-time and on schedule.
This role is ideal for a detail-oriented and highly organized individual with strong communication skills, proven cross-functional team leadership, and demonstrated experience in drug product manufacturing or new product introduction within a GMP-regulated environment.
location: Newbury Park, California
job type: Contract
salary: $40.00 - 47.11 per hour
work hours: 9 to 5
education: High School
responsibilities:
- Ownership over the Technology Transfer Project Planning, an activity that is vital to the impact that ATO B20 with a clinical and commercial product mix.
- Serve as a vital interface between the 5 key functions including: Manufacturing, Process Development, Supply Chain, Quality, and Facilities & Engineering.
- Drive decision-making and impose timelines.
- Knowledge of drug product technical process, manufacturing operations, scientific method, basic regulatory compliance expectations, and quantitative / analytical troubleshooting.
- Leading cross-functional projects to deliver NPIs on time through effective indirect people management and effective communication, both within and outside of the immediate team.
- Working with NPI support groups to develop, maintain, and implement the NPI project plan(s), being accountable for NPI scope, schedule, risk management, and leading matrixed teams through influence to meet NPI project milestones.
- Resolving issues in a timely manner and elevating cross-functional customer concern to various levels of management as appropriate.
- Owning Change Controls in Trackwise, ensuring records are comprehensive and compliant per GMP regulatory procedures. This must occur through a Right-First-Time approach.
- Proactively leading cross-functional team meetings, to ensure NPI project(s) and other relevant business cases execute per schedule.
- Succinctly communicating verbally, in writing, and through presentations to peers and senior leadership team.
- Engaging with Quality and Regulatory teams to ensure alignment and compliance across the network and with various agency submissions while delivering NPI project(s).
- Holding supporting functions accountable for delivery of NPI project tasks through documentation of Lessons Learned and presentation to management when appropriate.
- Reviewing protocols for manufacturing activities and partnering with Quality Assurance to ensure that GMP standards are maintained in line with current SOPs, batch record documentation, and licenses.
- Identifying improvement opportunities within the organization and taking proactive steps to build consensus to implement those opportunities.
- Performing purposeful presence Gemba walks in the manufacturing plant to identify process improvement opportunities as pertaining to NPIs and relevant lifecycle management strategies.
- Reporting on team and plant metrics to ensure visibility to team operations and deliverables.
- Representing the team at plant-wide and network-wide forums, as needed.
qualifications:
- Drug Product Manufacturing Experience / Pharmaceutical Product New Product Introduction Experience
- Proven ability to lead cross-functional teams and manage complex deliverables.
- Direct and/or indirect people management / leadership experience
- Understanding of Drug Product Formulation and Vial / syringe Filling operations
- Experience with various quality systems including change control, deviations, corrective and preventative actions, and/or validation practices
- Strong organization and technical writing skills; able to articulate complex problems concisely with technical and management staff
- Independent, self-motivated, able to multi-task in a fast-paced environment
- Team-player
- Demonstrated flexibility and ability to manage change
- Direct experience with regulated environments (e.g., cGMP etc.)
skills: Project Management, GMP (Good Manufacturing Practice), Manufacturing Operations, Process Engineering
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.
Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.
Qualified applicants in the unincorporated areas of Los Angeles County with criminal histories will be considered for employment in accordance with the Los Angeles County's Fair Chance Ordinance for Employers.
We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.
