About B. Braun 

B. 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 development.
• Conduct Extractables/Leachables studies for IV container closure materials such as resin, stoppers, inks, adhesives, etc. 
• 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 requirements.
• 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 activities.
• 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 techniques/products.
• Prepare necessary documentations to support regulatory submissions
• Collaborates with Senior/Principal Scientists and/or management to apply the results of research and develop new techniques/products.
• May provide guidance and training to and/or oversee the work of lower level associates and scientists

The 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 & Skills

• 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<661.1>, <661.2>, <381>, <87>, <88>, 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 action.
• 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 issues
• Judgement is required in resolving complex problems based on experience.
• Contacts are primarily with direct supervisor, peers and subordinates.

Expertise: Qualifications - Experience/Training/Education/Etc

Required:

• 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. candidates.
• Applicable industry/professional certification preferred.
• Occasional business travel required, Secrecy and invention agreement and non-compete agreement
• Regular and predictable attendance

Desired:

• N/A

While 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 expected to:

• 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 Reaching:

• Occasionally: Reaching upward and downward, Push/pull,
• Frequently: Standing, Sitting, Visual Acuity with or without corrective lenses
• Constantly: N/A

Activities:

• 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/A

Environmental Conditions:

• Occasionally: Proximity to moving parts, Exposure to toxic or caustic chemicals (in most areas)
• Frequently: N/A
• Constantly: N/A

Work 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

Equal Opportunity Employer Veterans/Disabled