Manager, QA Analytical
Company: Disability Solutions
Location: Severn
Posted on: October 16, 2024
Job Description:
Manager, QA AnalyticalPosition SummaryCatalent is a global,
high-growth, public company and a leading partner for the
pharmaceutical industry in the development and manufacturing of new
treatments for patients worldwide. Your talents, ideas, and passion
are essential to our mission: to help people live better, healthier
lives.--Catalent's Harmans/BWI, MD facility is a FDA-licensed,
state-of-the-art CGMP manufacturing facility for Gene Therapies.
The campus features two manufacturing facilities:The Harmans/BWI-1
EMA and FDA approved facility, at approximately 200,000 sq. ft.,
houses 10 CGMP manufacturing suites, fill/finish, central services,
testing labs, and a warehouse. The Harmans/BWI-2 facility, at
approximately 145,000 sq. ft., is under development and will house
8 CGMP manufacturing suites and cold storage warehousing. Both
facilities support Phase 3 through commercial manufacturing of
advanced therapeutic products including AAV and other viral
vector-based therapies and vaccines.The Manager, QA Analytical is
responsible for providing support and oversight to the QA
Analytical Team as they support the Analytical Development and
Quality Control departments, performing analytical method
development review of data generated as part of in-process, release
and stability testing of biopharmaceuticals.--This position is 1st
shift M-F 8AM-5PM and 100% on site. Position will spend 75% of time
at Harmans/BWI, Maryland facility and 25% of time at BioPark,
Maryland facility.Catalent is committed to a Patient First culture
through excellence in quality and compliance, and to the safety of
every patient, consumer and Catalent employeeThe Role:
- Manage the day-to-day QA operations in assigned area of QC
Analytical; ensure staff are fully trained on all cGMP
manufacturing operations and documentation and adhering to safety
guidelines; support the CAPA Tracking System and track the timely
completion and extension of commitments. --
- Build effective teams that apply their diverse skills and
perspectives to achieve common goals; drive engagement and create a
culture where employees are motivated to do their best; oversee
daily activity for the group to ensure quality results Performance
management for direct reports.
- Interface and communicate with the Client, Analytical
Development teams, Method Services group and the Quality Control
departments in meeting project timelines, providing deliverables
and resolving issues; perform quality review of documentation
including raw data, test methods, protocols and executed method
qualification/transfer/verification/validation reports and
stability protocols; review assay performed on systems such as
ELISA, DNA/RNA extraction and gel electrophoresis, qPCR, RT-PCR,
HPLC and Capillary Electrophoresis; support lot release by timely
reviews of COAs and COTs.
- Work with clients during initial and subsequent transfer of
assays and analytical methods to support GMP manufacturing
campaigns; support external client audits; Lead support of
regulatory (FDA, EMA) and client audits/inspections of Catalent.
--
- Implement continuous improvement initiatives; provide quality
oversight of process and analytical method development in an
R&D setting for client projects; provide quality oversight in
compliance with GMPs for Quality Control testing of clinical and
commercial product. --
- Support the Investigation and Deviation systems for tracking
statuses, follow-up, and liaison with applicable department
investigation writers to ensure their complete and timely
resolution. --
- Maintain databases and systems used for tracking various
activities; generate, revise and review Standard Operating
Procedures (SOPs) and other documentation as needed. --
- Continually evaluate systems and procedures for improvement for
efficiency and compliance to applicable regulatory requirements and
standards. --
- Proactively partners with Human Resources to attract and retain
top talent and takes an active role in ensuring new employee
onboarding is a success; work independently under general
supervision to meet company goals --
- Other duties as assigned.The Candidate:
- Masters' degree in a Scientific, Engineering or Biotech field
with 6+ years' experience Quality Assurance/Quality Control
function reviewing Analytical testing data for analytical assays
such as ELISA, DDPCR, HPLC, SDS-PAGE, Western blot or as an
Analytical Chemist with documentation review OR Bachelor's degree
in a Scientific, Engineering or Biotech field with 8+ years'
experience Quality Assurance/Quality Control function reviewing
Analytical testing data for analytical assays such as ELISA, DDPCR,
HPLC, SDS-PAGE, Western blot OR as an Analytical Chemist with
documentation review.--
- 2+ years Progressive Leadership experience, experience with
Performance Management, Goal Setting and Managing through Conflict.
--
- Proficient in Good Manufacturing Practices (GMPs), 21 CFR
210/211/600s, USP and ICH Guidelines. --
- Have the knowledge, and ability to apply basic scientific and
regulatory principles utilized to solve operational, as well as
routine quality tasks; exposure to Lean Operational Excellence
highly desirable; proficient in MS Office and related PC skills;
Strong communication skills.
- Ability to work in a lean, action-oriented organization and
demonstrate a strong work ethic; Must be flexible, adaptable,
self-motivated, and able to work well independently and across
teams and partners; must be team-oriented.
- Actively pursues learning of required skills, new skills, and
new equipment.The anticipated salary range for this position in
Maryland is $118,720-163,240 plus annual bonus, when eligible.
--The final salary offered to a successful candidate may vary, and
will be dependent on several factors that may include but are not
limited to: the type and length of experience within the job, type
and length of experience within the industry, skillset, education,
business needs, etc. Catalent is a multi-state employer, and this
salary range may not reflect positions that work in other states.
Why you should join Catalent:------- --Defined career path and
annual performance review and feedback process--------- --Potential
for career growth on an expanding team within an organization
dedicated to preserving and bettering lives--------- --Dynamic,
fast-paced work environment------- --Generous 401K match and Paid
Time Off accrual--------- --Medical, dental and vision benefits
effective day one of employment--------- --Tuition
Reimbursement--------- --Wellhub program to promote overall
physical wellness--------- --Perkspot - offers exclusive or private
discounts from approximately 900+ merchants in a wide array of
categories--Catalent offers rewarding opportunities to further your
career!-- Join the global drug development and delivery leader and
help us bring over 7,000 life-saving and life-enhancing products to
patients around the world. Catalent is an exciting and growing
international company where employees work directly with pharma,
biopharma and consumer health companies of all sizes to advance new
medicines from early development to clinical trials and to the
market. Catalent produces more than 70 billion doses per year, and
each one will be used by someone who is counting on us. Join us in
making a difference.--personal initiative. dynamic pace. meaningful
work.Visit to explore career opportunities.Catalent is an Equal
Opportunity Employer, including disability and veterans.If you
require reasonable accommodation for any part of the application or
hiring process due to a disability, you may submit your request by
sending an email, and confirming your request for an accommodation
and include the job number, title and location to . This option is
reserved for individuals who require accommodation due to a
disability. Information received will be processed by a U.S.
Catalent employee and then routed to a local recruiter who will
provide assistance to ensure appropriate consideration in the
application or hiring process.--------Notice to Agency and Search
Firm Representatives: Catalent Pharma Solutions (Catalent) is not
accepting unsolicited resumes from agencies and/or search firms for
this job posting. Resumes submitted to any Catalent employee by a
third party agency and/or search firm without a valid written &
signed search agreement, will become the sole property of Catalent.
No fee will be paid if a candidate is hired for this position as a
result of an unsolicited agency or search firm referral. Thank
you.Important Security Notice to U.S. Job Seekers:Catalent NEVER
asks candidates to provide any type of payment, bank details,
photocopies of identification, social security number or other
highly sensitive personal information during the offer process, and
we NEVER do so via email or social media. If you receive any such
request, DO NOT respond- it is a fraudulent request. Please forward
such requests to spam@catalent.com for us to investigate with local
authorities.California Job Seekers can find our California Job
Applicant Notice .
Keywords: Disability Solutions, Vineland , Manager, QA Analytical, Executive , Severn, New Jersey
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