Position summary: As an IP Tech Expert- at Johnson & Johnson, you will have the unique opportunity to apply your strong technical knowledge of analytical techniques and laboratory equipment in one or more areas such as Chemistry, Biochemistry, Bioassay, or Microbiology.
In this role, you will be responsible for qualifying analytical equipment and coordinating testing functions for various methods, including HPLC, Spectrophotometry, Nephelometry, Endotoxin, Cell Culture, and Total Organic Carbon.
Additionally, you will play a crucial role in coordinating and planning activities related to the successful transfer of Analytical Methods for relevant NMEs.
Your exceptional attention to detail and ability to successfully conduct QC activities will give to the flawless execution of our projects.
The individual will be responsible for: * Qualification of analytical equipment and related testing functions, for example HPLC, Spectrophotometry, Nephelometry, Endotoxin, Cell Culture and Total Organic Carbon etc.
* Sampling and testing coordination during plant and laboratory utility qualification.
* Co-ordinates & plans activities related to the successful transfer of Analytical Methods for relevant NMEs.
* Co-ordination of Raw material, Utilities, In Process, Final Bulk and Final product analytical testing and sampling.
* Support and Implementation of Analyst Training programs.
* Partners with other Departments and Team Leaders to ensure that activities related to QC are completed in an efficient manner.
General scope of responsibilities: In this role, you will collaborate with the Team Leader to support day-to-day testing operations and perform data and QC investigations review and approval.
You will have the opportunity to plan and coordinate lab-related projects, such as method transfers and equipment qualification, while proactively identifying and driving lab process improvements.
Your expertise will be critical in training the laboratory team on specific analytical technology and providing subject matter authority technical support.
Additionally, you will supply to lean initiatives in the area of lab operations and present technical analytical data clearly and concisely to customers, internal investigations, and regulatory inspectors.
Your ability to adapt and stay informed about the latest analytical technology and compliance trends will be key to your success.
KEY proficiencies REQUIRED: To excel in this role, you must possess the following proficiencies: * Teamwork and partnership.
* Proficient in Strategic Analysis.
* Problem solving and attention to detail.
* Results and performance driven.
* Coaching and mentoring style.
* Integrity, trustworthiness and objectivity.
* Customer focus.
* Clear interpersonal skills.
* Adaptable and flexible.
* Innovative.
* Inclusive, facilitative style.
Key individual contributor competencies: As a valued individual contributor, you will demonstrate the following competencies: * Builds strong positive relationships.
* Demonstrates ability to work with teams and individuals.
* Seeks opportunities to grow and develop professionally.
* Implements validated methods to enhance efficiency in business operations.
* Holds self accountable for compliant and detailed execution.
* Takes personal responsibility for decisions that successfully build customer value.
* Effectively manages and adapts to change.
* Demonstrates the courage to stand alone on ideas and opinions that differ from others.
* Listens optimally and remains open to other's ideas.
* Works effectively with people that have diverse styles, talents, and ideas.
Qualifications and experience: To be considered for this role, you must meet the following qualifications and experience: * Bachelor's Degree in Chemistry, Biochemistry, Microbiology, or a related field.
* 4-6 years of related experience in the biopharmaceutical or pharmaceutical industry, or an equivalent combination of education and experience.
* Solid understanding of regulatory requirements, policies, and guidelines, with experience in Quality Control document reviews and regulatory inspection processes.
* Working knowledge of Quality systems.
* Strong technical knowledge and experience with QC analytical testing methods and equipment.
* Knowledge of cGMP regulations and FDA/EU guidance.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.