Operations Manager - Scientific
Company: Kelly Services
Location: San Ramon
Posted on: April 9, 2021
Job Title: Operations ManagerWork Location: Hayward, CA.Job
Description:Our Client--is an emerging biotechnology focused on
biosample collection technologies. Our iSWAB-Microbiome product is
a disruptive technology being used in large quantities worldwide
for COVID-19 sample collection. We are seeking an experienced
Operations Manager to join our team. This is a new position and
excellent ground-floor opportunity with significant room for growth
and advancement.The--Operations Manager will have a proven track
record of setting up and running manufacturing and supply chain
operations, ISO compliance, procurement, and process automation for
high volume manufacturing in a regulated environment. This position
reports directly to the CEO and will play a key role in the
expansion of our--business as we transition into ISO certification
and FDA approval. The ideal candidate will be analytical,
experienced in collecting, processing and presenting data on
production levels, costs and capable of envisioning and justifying
new operations. The Operations Manager will be committed to finding
ways to improve operations while assuring that all quality
requirements are maintained and improved, and will have hands on
experience in general operations, facility management and capital
projects.To ensure success, you should have an understanding of the
FDA's QSR, ISO 13485 and applicable ISO standards as well as a
strong understanding of ERP systems, preferably the Netsuite
- Manage product manufacturing, packaging, labeling, and boxing
of all products.
- Manage inventory levels to assure growth targets can be
- Determine manufacturing equipment requirements; participate in
equipment specification, acquisition and qualification.
- Assure products meet quality requirements and are manufactured
per applicable standards.
- Implement and maintain ISO and /or other registrations as
- Working with QA, RA, and production staff to implement ongoing
cost savings and quality improvements. Modeling workflow, analyzing
potential automation alternatives. Evaluating potential
improvements to manufacturing workflow to improve output,
efficiency, lower cost and improve quality.
- Setting production schedules, material and manpower resources
to meet output objectives.
- Maintain a variety of reports, records and production
documentation to reflect schedules, performance, methods and the
- Assure, together with quality and leadership teams,
manufacturing compliance with GMP, ISO 13485.
- Create, execute and complete validation and qualification
- Support of the product and process development for new
products, product changes and enhancements.
- Parts receiving including incoming inspection and managing the
- Support equipment maintenance and support equipment service
- Establish process controls, statistical measures of
manufacturing performance and quality.
- Establish manufacturing objectives and metrics.--Requirements:
- You should have at least five years of relevant experience and
training in manufacturing, and or operations with excellent
communication skills and ability to build cross functional
- Bachelor's degree in business, accounting, engineering, or a
- Minimum of 5 years of experience in medical device or other
regulated manufacturing environment.
- Previous P&L responsibility preferred
- Relevant experience scaling to high volume production of
- Familiarity with FDA QSR and ISO 13485 medical device
- Ability to deliver under tight deadlines with a focus on
- Led successful manufacturing operations preferably with ISO
13485 control requirements.
- Strong oral and written communication and presentation skills.
Effective communicator of technical & non-technical
- Experience with managing processes and documents for GMP, ex:
- Authorized to work in the United States on a full-time basis,
full fluency (verbal and written) of the English language is a
- Working knowledge of PC applications software and manufacturing
- Must have the mindset and ability to thrive in an
entrepreneurial early stage company environment. Someone who is
resourceful and can work independently. Can effectively make
optimal use of limited resources and has an ability to work closely
with others in a small team setting.--#TJP2021_SPEC Why
Kelly--?Kelly Science & Clinical is your connection to premier
scientific and clinical companies looking to hire talented people
just like you. Every day, we match science professionals with dream
jobs that fit their skills and interests-it's the way we think job
searching should be. Nearly 100 percent of our science recruiters
have a professional background/education in science, so we know a
thing or two about the science market and how to get you
noticed.About Kelly--At Kelly, we're always thinking about what's
next and advising job seekers on new ways of working to reach their
full potential. In fact, we're 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. 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 is an equal opportunity employer committed to
employing a diverse workforce, including, but not limited to,
minorities, females, individuals with disabilities, protected
veterans, sexual orientation, gender identity. Equal Employment
Opportunity is The Law.]]
Keywords: Kelly Services, San Ramon , Operations Manager - Scientific, Executive , San Ramon, California
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