Sr. Research Scientist I
Company: B. Braun Medical
Posted on: September 18, 2022
B. Braun Medical, Inc.
Sr. Research Scientist I
Job ID: 2022-20389
Type: Regular Full-Time
# of Openings: 1
About B. BraunB. Braun Medical Inc., a leader in infusion therapy
and pain management, develops, manufactures, and markets innovative
medical products and services to the healthcare industry. Other key
product areas include nutrition, pharmacy admixture and
compounding, ostomy and wound care, and dialysis. The company is
committed to eliminating preventable treatment errors and enhancing
patient, clinician and environmental safety. B. Braun Medical is
headquartered in Bethlehem, Pa., and is part of the B. Braun Group
of Companies in the U.S., which includes B. Braun Interventional
Systems, Aesculap - and CAPS -.Globally, the B. Braun Group of
Companies employs more than 61,000 employees in 64 countries.
Guided by its Sharing Expertise - philosophy, B. Braun continuously
exchanges knowledge with customers, partners and clinicians to
address the critical issues of improving care and lowering costs.
To learn more about B. Braun Medical, visit www.BBraunUSA.com.
Position Summary:This scientist position is with the B. Braun
Pharmaceutical Research & Development department. The incumbent
shall provide relevant subject matter expertise in formulation and
analytical development to progress Pharmaceutical R&D portfolio
from the innovation phase to commercial product realization (Para
I-IV ANDA, PAS, 505b (1)/(2) NDA categories). The pharmaceutical
portfolio includes: Injectable drugs & Premixes, Duplex - systems,
Parenteral nutrition, and Intravenous fluid replacement
therapies.Responsibilities: Essential Duties
- Evaluate, design and conduct analytical method development to
enable early and late stage pharmaceutical product
- Conduct Extractables/Leachables studies for IV container
closure materials such as resin, stoppers, inks, adhesives,
- Independently set up and operate analytical instrumentations.
Perform troubleshooting as needed.
- Conduct chemical impurity identification and characterization
to guide regulatory strategy.
- Elucidate chemical reaction mechanisms and structures and
provide hypothesis on possible degradation and/or interaction
pathways of active ingredient(s) in drug product formulations.
- Review works, results, data, reports and any other documents
generated by peer staff to ensure compliance with current GMP/GLP,
specifications, standard operating procedures, and regulatory
- Prepare summary reports and presentations for review by senior
management, and in support of regulatory interface meetings.
- Author pertinent protocols, report, pharmaceutical development
reports and CMC sections for regulatory filling.
- Continue to develop expertise in areas related to analytical
development and drug degradation pathways.
- Publication in peer review journals and presentation at
internal/external scientific forums is highly encouraged.
- Plans, organizes, and conducts experiments and research
- Builds and tests new designs, formulations, materials, or
systems for compliance with quality and/or performance standards.
Processes, and analyzes results and data.
- Applies the results or research and develops new
- Prepare necessary documentations to support regulatory
- Collaborates with Senior/Principal Scientists and/or management
to apply the results of research and develop new
- May provide guidance and training to and/or oversee the work of
lower level associates and scientistsThe job function listed is not
exhaustive and shall also include any responsibilities as signed by
the supervisor from time to time.General: It shall be the duty of
every employee while at work to take reasonable care for safety and
health of himself / herself and other person.Expertise: Knowledge &
- Hands-on expertise in analytical and physical characterization
technologies, including HPLC, GC, UV, FTIR, MS, NMR, TGA, DSC and
complex analytical techniques is required.
- Expertise in chemical impurity identification and
characterization in related to drug degradation pathways.
- Expertise in analytical method development/validation.
- Expertise in extractables/leachables study and evaluation.
- Requires full working knowledge of professional field and
pharmaceutical industry in cGMP environment.
- Must have demonstrated experience and subject matter expertise
in one of more of the role relevant areas: formulation development,
drug delivery, combination products, preformulation, reaction
mechanisms / organic chemistry, analytical chemistry, pharmaceutics
and material science.
- Working knowledge of chemical theories, concepts, test methods
and instrumental methods, analytical and research skills
- Broad understanding and knowledge of USP, EP, cGMP/GLP, FDA CFR
& ICH regulations and guidelines.
- Experience of polymer characterization with USP, , , , ,
ISO-10993 evaluation for materials used for pharmaceutical and
medical device is plus.
- Thorough understanding of the pharmaceutical development
process and regulatory workflows (IND, ANDA, NDA etc.) with focus
on injectable drugs or combination products.
- Strong communication (written and verbal), attention to detail
and organizational skills as demonstrated in writing project
proposals, protocols and reports.
- Scientific contribution skills as demonstrated by posters,
presentations, patents or presentations.
- Please refer to the Corporate Guidelines or BBMUS Guidelines or
job specific authorities where applicable.
- This list is however not exhaustive and may be amended by the
Management from time to time.
- Requires advanced knowledge of professional field and industry.
Influences the development of and drives the application of
principles, theories, concepts. Determines best course of
- Work under minimal supervision. Relies on experience and
judgement to plan and accomplish assigned goals. May periodically
assist in orienting, training, assigning and checking the work of
lower level employees. Referring only complex problems and
- Judgement is required in resolving complex problems based on
- Contacts are primarily with direct supervisor, peers and
Expertise: Qualifications -
- PhD required or equivalent combination of Master's degree and
directly relevant experience and certifications.
- 10-12 years related experience required.
- Pharmaceutical Industry or a directly relevant post-doc
experience, of 4-8 years for Ph.D. and 6-10 years for M.S.
- Applicable industry/professional certification preferred.
- Occasional business travel required, Secrecy and invention
agreement and non-compete agreement
- Regular and predictable attendanceDesired:
- N/AWhile performing the duties of this job, the employee is
regularly required to sit and talk or hear. The employee frequently
is required to use hands to handle or feel and reach with hands and
arms. The employee is occasionally required to stand and walk. The
employee must occasionally lift and/or move up to 20 pounds.B.
Braun offers an excellent benefits package, which includes
healthcare, a 401(k) plan, and tuition reimbursement. To learn more
about B. Braun and our safety healthcare products or view a listing
of our employment opportunities, please visit us on the internet at
www.bbraunusa.com.Through its "Sharing Expertise -" initiative, B.
Braun promotes best practices for continuous improvement of
healthcare products and services.
Responsibilities: Other Duties:Physical Demands:The physical
demands described here are representative of those that must be met
by an employee to successfully perform the essential functions of
this job. Reasonable accommodations may be made to enable
individuals with disabilities to perform the essential
functions.While performing the duties of this job, the employee is
- Moderate work - Exerting up to 40 lbs. of force occasionally,
and/or up to 20 lbs of force frequently, and/or 10 lbs of force
constantly to move objects.Lifting, Carrying, Pushing, Pulling and
- Occasionally: Reaching upward and downward, Push/pull,
- Frequently: Standing, Sitting, Visual Acuity with or without
- Constantly: N/AActivities:
- Occasionally: Push/pull, Reaching upward and downward, Talking
- ordinary, loud/quick, Walking
- Frequently: Hearing - ordinary, fine distinction, loud (hearing
protection required), Seeing - depth perception, color vision,
field of vision/peripheral, Sitting, Standing
- Constantly: N/AEnvironmental Conditions:
- Occasionally: Proximity to moving parts, Exposure to toxic or
caustic chemicals (in most areas)
- Frequently: N/A
- Constantly: N/AWork Environment:The work environment
characteristics described here are representative of those an
employee encounters while performing the essential functions of
this job. Reasonable accommodations may be made to enable
individuals with disabilities to perform the essential functions.
- Noise Intensity: Moderate
- Occasionally: Production/manufacturing environment
- Frequently: Office environment, Lab environment
- Constantly: N/A
What We Offer
Equal Opportunity Employer Veterans/Disabled
All qualified applicants will receive consideration for employment
without regard to race, color, sex, sexual orientation, gender
identity, religion, national origin, disability, veteran status,
age, marital status, pregnancy, genetic information, or other
legally protected status.
Keywords: B. Braun Medical, Irvine , Sr. Research Scientist I, Other , Irvine, California
Didn't find what you're looking for? Search again!