1+ months

Downstream Process Development Supervisor

Kelly Services
Carlsbad, CA 92008
**Job Title: Downstream Process Development Supervisor**

**Location: San Diego, CA**

**Work Type: Direct-Hire, On-Site, Full-Time**

**Job Summary:**

At Microbial Material Services (MMS), a new Business Unit we deliver, from process development through commercial supply, the expertise and resources necessary to help clients deliver innovative plasmid-based therapeutics as critical raw materials, drug substances, and drug products. Placed in the forefront of our leading- and cutting-edge Cell and Gene Therapy businesses enabling clients to cure genetic, rare, and otherwise untreatable diseases as their CDMO of choice.

**How will you make an impact?**

You will provide the cross functional leadership, operations acumen, and results focus to reliably meet and/or exceed product supply targets while achieving high levels of quality. You will partner across the site to implement robust business processes to support the successful planning, production, testing, and release of product in a fast-paced production environment

**What will you do?**

+ Subject matter expert in Downstream purification techniques, particularly as it relates to plasmid purification.

+ Leads/oversees design of experimental plans and studies and troubleshoots design flaws to ensure studies are scientifically sound.

+ Conducts complex analyses to support process development.

+ Sets guidelines for recording of results and reviews documentation by others.

+ Oversees preparation of protocols, reports, and work instruction required for process implementation.

+ Maintains and ensures safe laboratory environment and work practices.

+ Take one or more complex projects with significant program, client, or site impact.

+ Acts as technical lead on multiple programs, with responsibility for running those programs and other PD/AD personnel on the programs.

+ Collaborates with Program Management to ensure clear expectations and successful deliverables.

+ Coach, lead, and enable others to deliver objectives efficiently and with high degree of quality.

+ Make program level decision on process development items including critical investigations and process improvement/optimization.

+ Provide daily oversight on Downstream development activities at Carlsbad site.

+ Provide technical and scientific support through schedule balancing and coaching

+ Recruit and develop staff to execute department functions; ensure effective utilization of resources through strong people leadership including consistent performance management, robust employee development and routine rewards and recognitions practices.

+ Supervise teams of junior scientists or technicians to achieve milestones and deliverables.

+ Set team goals and effectively delegate work.

+ Partner with clients, manufacturing sciences, and program managers to facilitate technical transfer of client processes, development / revision of procedures, and establishing process and equipment training for the staff.

+ Plan resourcing at the group level with multi-year outlook to fulfill business objectives.

+ Assist in establishing department / individual goals and key performance indicators in alignment with company and operational goals; maintain and report applicable department and delivery metrics.

+ Help drive continuous improvement and Operational Excellence culture thru self-detecting and self-correcting processes and systems and instilling strong ownership and accountability.

+ Ensure the safety of assigned areas and work practices in accordance with site and company EHS programs.

+ Ensure that the Process Development rooms operate efficiently (schedule; material staging, facilities cleaning, maintenance, calibration) and all activities are appropriately documented.

+ Works with MST, Manufacturing, and Analytical Development/QC groups to trouble-shoot and optimize purification processes and testing challenges.

+ Expertise in functional area recognized throughout entire organization. Knowledge and expertise may be leveraged throughout organization and not limited to site.

+ Remains current in the field by review of relevant scientific literature and attendance at appropriate scientific seminars and conferences.

**How will you get here?**


+ Bachelors in Life Sciences, Engineering, Biochemistry, Biology or related field with 5+ years of industry experience

+ Masters with 3+ years or Ph.D, preferred

+ Minimum of 2 years supervising experience

+ Demonstrated ability to motivate exempt and non-exempt employees and demonstrated management skills, (i.e., business knowledge, leadership, communication, ability to analyze technical issues, conflict resolution)


+ Small- and large-scale Purification experience, preferably in a CDMO

+ Extensive knowledge of purification automation

+ Knowledge of DOE and process optimization

+ Analyzing and presenting data

+ Ability to function in a fast paced, dynamic environment with multiple priorities simultaneously

+ Strong planning, organization and multitasking skills

+ Strong interpersonal and communication skills and the ability to work effectively with a wide range of constituencies in a diverse community

+ Ability to make decisions and work with minimal to moderate supervision

+ Able to provide effective written or verbal communication to peers, senior associates, and area management within their operational groups

+ Solid understanding of applicable regulatory requirements

_Knowledge, Skills, Abilities_

+ Leading and supporting a team

+ Managing multiple projects

+ Problem solving and critical thinking

+ Strong interpersonal and communications skills; written and oral

+ Solid understanding of applicable regulatory requirements

+ Strong working knowledge of Microsoft Office

+ Ability to deliver high quality documentation paying attention to detail

**_For immediate consideration apply today!_**

**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.

**Why Kelly** **** **Science & Clinical?**

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the worlds most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goalsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

**About Kelly** ****

At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kellys Human Resource Knowledge Center.
Kelly complies with the requirements of Californias state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.
Posted: 2022-07-29 Expires: 2022-10-15

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Downstream Process Development Supervisor

Kelly Services
Carlsbad, CA 92008

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