Senior Scientist, I Parenteral and Eyecare Product Development S&T ( On-site, CA)

Allergan; Irvine (CA); On-site; USD 80,000 - 120,000; Full time

Job summary

An innovative company is seeking a Senior Scientist to lead the design of groundbreaking formulations and robust manufacturing processes for ophthalmic drug products. This role involves applying scientific principles and advanced methodologies to enhance product development and life-cycle management. Collaborating with cross-functional teams, you will ensure compliance with regulatory standards while driving innovation in formulation sciences. If you are passionate about making a significant impact in the pharmaceutical industry and possess strong leadership and problem-solving skills, this opportunity is perfect for you.

Benefits

Paid Time Off

Medical/Dental/Vision Insurance

401(k) Plan

Short-term Incentive Programs

Qualifications

• 8+ years of experience in formulation sciences and manufacturing.
• Strong understanding of aseptic manufacturing processes.
• Experience with FDA regulations for CMC issues.

Responsibilities

• Plans and executes formulation and process development activities.
• Coordinates scale-up and transfer of new processes.
• Generates and maintains documentation for regulatory compliance.

Skills

Laboratory Skills

Formulation Screening

Manufacturing Process Development

Scientific Problem Solving

Statistical Applications

Education

Bachelor's in Chemical Engineering

Master's in Pharmaceutical Sciences

PhD in Chemistry

Tools

ELN (Electronic Lab Notebook)

Technical Report Writing

Job description

Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us atwww.abbvie.com. Follow @abbvie onX,Facebook,Instagram,YouTube,LinkedInandTik Tok.

Job Description

The PDS&T Parenterals/Eye Care group is seeking a motivated Senior Scientist to design innovative formulations and develop robust manufacturing processes for clinical phase and commercial products of ophthalmic drug products. This person will apply scientific principles as well as QbD and DoE approaches to systematically design and conduct scientific experiments and provide critical analysis and interpretation of the data, conducts studies in the area of formulation and process development in support of product innovation and life-cycle management of marketed products. This position will be an integral part of the product development and CMC teams and is highly collaborative across functions such as analytical, microbiology, device engineering, internal and external manufacturing, quality assurance, CMC regulatory affairs, supply chain and Operations Manufacturing Sites.

Responsibilities:

• Plans, directs, and executes formulation and process development activities in support of development of new products intended for clinical trials and commercialization. Conducts research in the area of formulation sciences and manufacture technologies in support of innovative product and process development and life-cycle management of marketed products.
• In concert with QA and Manufacturing Support groups, coordinates the activities required to scale-up and transfer new process from pilot-scale to clinical and commercial-scale at the designated site of manufacture.
• Provides scientific and technical leadership on one or more areas of formulation sciences and manufacture technologies. Develops and maintains a current basic knowledge of global CMC regulatory submission requirements, GLP/GMP requirements & device regulations (ISO). Reviews internal and external technical documents, writes technical memos/reports, patents, scientific articles.
• Represents department at project/CMC/Technology Transfer teams and works closely with other analytical, microbiology, device engineering, internal and external manufacturing, quality assurance, CMC regulatory affairs, supply chain and Operations Manufacturing Sites to meet project timelines and objectives.
• Generates and maintains all required documentation including logbooks, lab notebooks, development/technology reports and manufacturing records to ensure products and processes are developed according to internal and regulatory guidelines.
• Maintains current knowledge level of formulation sciences and manufacture technologies by regularly reviewing technical literature, regulatory documentation and attending technical training courses to ensure that work performed is in accordance with the latest technical and regulatory information.

Qualifications

• Bachelors, Masters, or PhD in chemical engineering, pharmaceutical sciences, chemistry, pharmaceutics, or related disciplines with 8+ (Bachelors), 5+ (Masters), or 1-2 (PhD) years of relevant industry experience.
• Strong laboratory skills and experience focused on formulation screening, manufacturing process development for sterile liquid formulations.
• Scientific problem solving, experimental design, and trouble shooting skills.
• Solid understanding of the various unit operations of aseptic manufacturing such as compounding/mixing, filtration, filling for liquid products.
• Experience in laboratory documentation systems, including ELN, and demonstrated experience with technical report writing. Technical understanding and experience with small molecule products manufacturing, development, quality and analytics is required.
• Knowledge and experience with FDA and global regulatory requirements for CMC issues is required.
• Demonstrated excellence in writing, presentation, and overall communication.
• Must be able to operate as a functional area leader and utilize knowledge of pharmaceutical science, chemical engineering, literature and experience to guide decisions in complex situations.
• Knowledge of fundamental applications of statistics is preferred.

Computational modeling experience is a plus.

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

• The compensation range described below is the range of possible base pay compensation that the Company believes ingood faith it will pay for this role at the time of this posting based on the job grade for this position. Individualcompensation paid within this range will depend on many factors including geographic location, and we may ultimatelypay more or less than the posted range. This range may be modified in the future.

• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/visioninsurance and 401(k) to eligible employees.

• This job is eligible to participate in our short-term incentive programs.

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, and determinable.The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefitsthat are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid andmay be modified at the Company’s sole and absolute discretion, consistent with applicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visithttps://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html