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Posted: Monday, January 8, 2018 8:04 AM

Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.

I: Job Summary

The Analyst III position will design and prepare all protocols and reports related to novel and diverse validation activities. The candidate will focus on Process Validation and Technical Transfer/ Development Activities leading up to Process Validation. The Analyst III will network with senior internal and external personnel in their area of expertise and work on problems where analysis of data requires evaluation of identifiable factors and troubleshooting of abnormalities. Considerable judgment and initiative, as well as a scientific background are essential in identifying and resolving problems and making recommendations.

II: Responsibilities

Key Duties will include:

* Critically review complex data to ensure completeness, accuracy and compliance.

* Works on complex problems in which analysis of processes or data requires an in-depth evaluation of various factors with minimal over sight. Exercises judgement in selecting methods, techniques and evaluation criteria.

* Works independently and may provide guidance to lower level personnel or as a team member. Execute QbD experiments to support the development and characterization of new manufacturing processes.

* Independently manage multiple cross-functional projects that may require regulatory submissions.

* Effectively present complex technical information to guide decision making.

* Support regulatory services with CMC preparation, product reviews and Client and Regulatory audits.

* Author technical documents such as protocols, reports, deviations, gap analyses, risk assessments, etc.

* Function as the SME for Manufacturing processes, Process Validation and Technical Transfer of new products in regard to validation, compliance and product quality.

* Perform Cleaning Validation and Cleaning Validation and Cross Contamination Evaluations.

* Provide technical and/or investigational support in troubleshooting and resolving manufacturing process issues.

* Perform periodic review of processes/ systems.

* Support Business Development with the evaluation of safety and feasibility for potential new products.

* Write and execute validation and revalidation protocols and reports (IQ/OQ/PQ) for the validation of new and existing processes and systems, etc.

* Write and revise SOPs and Master Plans biennially or as part of process improvements.

* Maintain close contact with Production, Technical Services, and Analytical Services, to assure effective communication on validation issues.

* Apply CGMP and CGDP to all areas of work.

* Assist with commissioning FATs/SATs.

The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned.

III: Education, Experience & Skills

BS in Science or Engineering with minimum of 7 years of equivalent job experience in pharmaceutical manufacturing.

* Strong leadership skills; high level of personal/departmental accountability and responsibility.

* Ability to manage multiple priorities and tasks in a dynamic environment.

* Excellent written and verbal skills.

* Experience and knowledge of sterile processing (rooms, equipment, HVAC, etc).

* Ability to exercise judgment to determine appropriate corrective actions.

* Ability to exercise judgment for defined practices and policies in selecting methods and techniques for obtaining solutions.

* Ability to use computer programs such as eDocs and SAP.

* Ability to work in a team environment.

* Proficient knowledge of CGMP.

* Coordinate multiple tasks simultaneously.

* Ability to make sound decisions regarding compliance-related issues with minimal supervision and guidance.

* Regulatory background in pharmaceutical development/research is a plus.

IV: Physical/Mental Requirements

* Type/keyboard, stand, walk, sit. Use phone, fax, copier, and computer. Organize/coordinate, analyze/interpret, problem solve, make decisions, supervise, plan, communicate, prepare written communications, and prepare transaction documents.

Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.

Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy .

\"UNDER MARYLAND LAW, AN EMPLOYER MAY NO REQUIRE OR DEMAND, AS A CONDITION OF EMPLOYMENT, PROSPECTIVE EMPLOYMENT, OR CONTINUED EMPLOYMENT, THAT INDIVIDUALS SUBMIT TO OR TAKE A LIE DETECTOR OR SIMILIAR TEST. AN EMPLOYER WHO VIOLATES THIS LAW IS GUILTY OF A MISDEMEANOR AND SUBJECT TO A FINE NOT EXCEEDING $100.\"

Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions' approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions' approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.

SDL2017


Associated topics: biochemistry, biomedical, biomedical engineer, msat, neuro, neurodegenerative, neuroscience, pain, pharmaceutical, therapeutic

Source: http://www.jobs2careers.com/click.php?id=4641385315.96


• Location: Baltimore

• Post ID: 29850827 baltimore
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