="text-align: center;">Abbvie Lead Chemist/Engineer Job – Chemistry & Pharmaceutical Science
Abbvie hiring Lead Chemist / Senior Technical Operations Engineer. Chemistry and pharmaceutical science job opening 2022, Chemistry job opening 2022. MSc Pharmaceutical science job vacancy 2022. Chemistry job vacancy 2022. Intrested and eligible candidates may check out all the details on the same below:
Job Title: Lead Chemist / Senior Technical Operations Engineer
Job Id – 2204844
Eligibility Criteria:
- Bachelors/Masters/PhDs degree In a technical/science field, including Chemistry or Pharmaceutical Sciences
- For Senior, 4 to 8 years of relevant experience with a bachelor’s degree; 2 to 6 years of relevant experience with a Masters’s degree and. or 0 to 4 years of relevant experience with a Ph.D. and technical experience in process chemistry, pharmaceutical manufacturing process, tech transfer, commissioning and validation in the pharmaceutical industry.
- For Lead, minimum 15 years of technical experience in process chemistry, pharmaceutical manufacturing process, tech transfer, commissioning, and validation in the pharmaceutical industry.
- Detailed Knowledge of cGMP and regulatory requirements relating to the pharmaceutical industry is required
- Demonstrated process development skills, including the ability to deliver innovative process chemistry at scale. Proven scale-up skills, to facilitate the successful transition from laboratory to full-scale production.
- Experience of start-ups and new product introduction to commercial facilities is preferred.
- Good problem-solving skills, embrace problem-solving tools like FMEA, 5 Why, able to work under pressure and tight timeline.
- Team player, highly self-motivated, and able to work under minimum supervision.
- Good command in oral and technical writing in English, and excellent communication and presentation skills.
Purpose Statement
Responsible for manufacturing support of clinical and commercial API processes. Technical subject matter expert for all manufacturing and chemistry-related issues. Provides rapid response to operational issues and supports ongoing operations including new product introduction, process optimization, monitoring, and cleaning. Knowledge of common API analytical techniques and lab work for confirming process chemistry and material qualification. Provides leadership, training, and coaching to team and manufacturing personnel.
Job Responsibilities:
- Support facility start-up and assist in plant equipment and facility validation and qualification activities.
- Supports manufacturing activities during the technology transfer, qualification and validation batches associated with new product introductions to the site.
- Supports operational efficiency goals for yield, product quality and other product and/or site KPI’s.
- Contact and consultant for process/equipment troubleshooting and investigation activities.
- Actively promotes a culture of GMP and EHS compliance with all applicable policies and guidelines and supports risk assessment activities by providing relevant technical knowledge.
- Provides support to regulatory filings and audit activities.
- Provides support for process cleaning/changeover strategies (CIP/SIP), media/solution preparation, and benchtop analytics as required.
- Authors for technical reports, batch records, SOP’s, investigations, and protocols as required and ensures consistency and quality of the group’s documentation.
In addition to the above job responsibilities, the Lead is to perform the followings:
- Provides leadership in manufacturing activities, during the technology transfer, qualification, and validation batches associated with new product introductions to the site.
- Provides technical expertise related to manufacturing process and equipment in response to deviations, and design of experiments as appropriate to understand and eliminate the root cause(s). Support investigations from a chemistry/process perspective for product complaints and deviation.
- Identify and develop necessary laboratory experiments for continuous improvement projects. Work closely with process engineers and other departments to deliver these continuous improvement projects including change control management.
- Participate in PHA and quality risk assessment activities providing relevant technical knowledge related to process chemistry and safety.
- May supervise a team of 1 to 5 direct reports
- Any other duties as assigned by supervisor.
Apply Online
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