Msat Sr. Associate Scientist

Description

Johnson and Johnson is seeking for a MSAT Sr. Associate Scientist to join our TEAM!

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.  

Are you interested in joining a diverse team delivering outstanding results to our patients through our Innovative Medicine products? Apply now for this exciting role!

The Senior Associate Scientist is responsible for giving continuous support to the following validation programs: Production Equipment (moist heat / depyrogenation), Filter Qualification, Re-qualifications, Cleaning validation, Processes validation, Packaging Qualifications, and Aseptic Process Simulation (APS). The incumbent is also responsible for the execution of the different project steps and coordinating activities with the different units of the Janssen Cilag Manufacturing, LLC organization as the need arises. This position enables the company to be in compliance with the current regulatory requirements of the pharmaceutical industry.

Key Responsibilities:

• Implement process, cleaning, sterilization process, machine-abilities, packaging qualifications, and APS studies.
• Search for literature to understand the systems, equipment and processes presently used in our GMP related operations.
• Develop validation protocols based on available literature, company procedures, guidelines, and regulations.
• Coordinate with other departments and implement all the activities required for the validation program.
• Compile, review and analyze validation data and summarizes results and conclusions in technical reports.
• Preparation of Technical Reports (RPT’s) to document technical activities in support of regulatory compliance and submissions.
• Preparation of protocols to evaluate alternate components and raw materials, alternate methods of manufacture, process and product anomalies, cost savings opportunities, and process, equipment, and cleaning validation.
• Provide technical support to basic level investigations and resolution of process deviations.
• Initiate Change Controls and complete technical / validation assessments to changes owned by other functional groups.
• Provides technical training in technical areas such as: qualification, validation, technical transfer, and new process implementation.
• Special Project execution / coordination.
• Participate and provide technical expertise in the critical review of all document associate with the manufacturing of sterile products.
• Coordinate and/or implement aseptic processing special projects to accomplish company goals and objective on the timely and effective manner.
• Collaborate directly with manufacturing operations to ensure that appropriate environmental and aseptic procedures are in place, through the execution of comprehensive reviews of procedures against practice.
• Work with other teams to address technical issues and resolve them using sound scientific reasoning and technical expertise.
• This role may include the responsibility to propose, implant, validate changes related to manufacturing / packaging areas
• Identify areas of process improvements. Works with technical groups to implement process improvements. May lead process improvements initiatives depending on complexity.
• Participate in audits. Supports regulatory agency interactions.

Qualifications

Education:

• A Bachelor's Degree in Chemistry, Pharmacy, Biochemistry, Chemical Engineering or related Science or Engineering is required.

Experience and Skills:

Required:

• A minimum 2 years of relevant work experience
• Knowledge of cGMP's, FDA regulations, and pharmaceutical manufacturing equipment
• Must have knowledge of aseptic manufacturing process
• Experience in a Technical support or Manufacturing environment in the pharmaceutical / medical device or similar industry
• Knowledge on Technical support, computer literature, collaboration
• Able to work in a manufacturing environment of Parenteral
• Proficiency in the use of MS Office applications: Word, Excel, Power Point
• Must be fluent in Spanish and English and have excellent writing and good communication skills
• Works effectively and collaboratively with a broad cross section of functional areas
• Ability to work with moderate supervision and make appropriate decisions
• Excellent team skills in a multi-cultural environment
• Knowledge of pharmaceutical validation / qualification
• Ability to work several tasks at the same time. Interpersonal skills. Establishment of Priorities
• Able to work under time pressure, validated leadership skills
• Ability to work with strict deadlines with sense of urgency
• Strong communication and excellent presentation skills
• Work with precision

Preferred:

·       Knowledge of MCA & Japan regulations, lyophilization technology, utilities and environmental controlled areas, packaging, process, and cleaning validation.

• Critical thinker, ability for problem solving, knowledge of basic statistical tools
• Technical knowledge in pharmaceutics / formulation process
• Knowledge of Process Critical Parameters. Optimization of production processes
• Ability to manage multiple priorities
• Experience in defining problems, collecting data, establishing facts, and draw valid conclusions
• Ability to calculate numbers and quantities and work with proportions percentages
• Experience and/or knowledge to read, interpret, and analyze documents such as technical reports, risk assessments, procedures, Master Batch records and other complex documents
• Work in teams and independently
• Ability to follow and interprets a wide range of instructions in technical and mathematical form
• Solid decision making skills

Other:

• Requires up to 10% domestic and international travel
• Requires to carry less than 10 pounds occasionally

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com .