- Develop preclinical and clinical formulations, including liquid and lyophilized dosage forms, and related drug product manufacturing processes.
- Transfer drug product manufacturing process to internal and external fill-finish facilities and provide on-site support as needed.
- Design lyophilization cycle studies for drug product manufacturing and optimize developed lyophilization cycle processes to manufacture freeze-dried drug products.
- Support development stability and clinical in-use studies to guide dose solution administration.
- Generate high-quality data based on sound scientific principles and prepare formulation data summaries, technical reports, scientific presentations, and regulatory documents.
- Participate in drug product development teams and contribute to the planning and execution of product development studies including formulation and drug product process development, based on project goals and timelines.
- Actively interact with CMC members and other AbbVie stakeholders to enable the successful development of AbbVie drug products.
- Drive innovation by investigating and developing novel experimental approaches and/or technologies in the field of drug product development and raise visibility within the scientific community through external presentations and publications.
Qualifications - Ph.D in Pharmaceutical Sciences, Chemical Engineering, Analytical Sciences, Biochemistry or equivalent field with 0-3 years of experience or BS/MS degree with 8-10 years of relevant experience in the biotechnology or pharmaceutical industry
- A strong technical background encompassing protein chemistry, analytical development, and formulation development is required.
- Candidates with hands-on expertise in analytical techniques used for protein characterization and stability studies (e.g liquid chromatography (SEC, ion exchange, HIC), DSC, CD and Fluorescence spectroscopy, sub-visible particle characterization, DLS, Karl Fisher) will be preferred.
- Technical expertise and practical experience in lyophilization process development of proteins/biologics as well as solid-state characterization are highly desirable. Prior experience in aseptic manufacturing process development, scale up, and technical transfer is a strong plus.
- Preference to candidates with demonstrated experience in solving problems and driving innovation.
- Excellent communication and written skills are required.
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 pay is considered to be wages 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 Companys sole and absolute discretion, consistent with applicable law. AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVies policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.
-
Manufacturing Product Development Engineer
6 days ago
Alloy Engineering Co Berea, United StatesJob Description · Job DescriptionDescription:Summary: The Product Engineer will apply knowledge of product design, product environment, fabrication, assembly, tooling, and materials to best meet customer requirements. The Product Engineer improves upon the performance and design ...
-
Nighttime Warehouse Supervisor
2 weeks ago
ADUSA Supply Chain Disputanta, United States**Position Summary**: · Oversee the department functions, associates, and meets and maintains production standards for receiving or shipping department assigned. Handles all daily issues and projects under the direction of the Operations Manager. Works with all Distribution Cente ...
-
Dc 20 Warehouse Supervisor
20 hours ago
ADUSA Supply Chain Disputanta, United States**Position Summary**: · Oversee the department functions, associates, and meets and maintains production standards for receiving or shipping department assigned. Handles all daily issues and projects under the direction of the Operations Manager. Works with all Distribution Cente ...
-
Style Team Leader
1 week ago
Target Menifee, United StatesThe pay range per hour is $ $40.80 · **ALL ABOUT TARGET** · Working at Target means helping all families discover the joy of everyday life. We bring that vision to life through our values and culture. Learn more about Target here. · **ALL ABOUT STYLE** · The Style team is passion ...
-
Sales Representative
1 week ago
Vidal Empire Menifee, United StatesJoin our dynamic team at Vidal Empire as a Sales Representative based in the Temecula area We're a leading provider in the telecommunications industry, specializing in selling products and services to enhance connectivity and communication. At Vidal Empire, we're passionate about ...
-
General Laborer
6 days ago
Matthews International Corporation Menifee, United States**General Laborer**: · - Brand: Matthews Memorialization- Company: The York Group, Inc.- Line of Business: Granite- Location: Menifee, CA, US, Req ID: 12280***: · The General Laborer performs laboring tasks required at varying work areas, i.e. molding operations, pour operations, ...
-
Team Member: Store 1377
1 week ago
Del Taco Menifee, United States**Our Team Members are responsible for being at their very best and creating an amazing guest experience. Our Team Members create a culture in our restaurants that is exciting, optimistic and rewarding. The overall success of our restaurants and the foundation of our culture is d ...
-
Dog Trainer
5 days ago
Petco Menifee, United StatesCreate a healthier, brighter future for pets, pet parents and people · If you want to make a real difference, create an exciting career path, feel welcome to be your whole self and nurture your wellbeing, Petco is the place for you. · Our core values capture that spirit as we wor ...
-
Vault Assembly Operator
5 days ago
Matthews International Corporation Menifee, United States**Vault Assembly Operator**: · - Brand: Matthews Memorialization- Company: The York Group, Inc.- Line of Business: Granite- Location: Menifee, CA, US, Req ID: 12284***: · The Vault Assembly Operator produces quality cement burial vaults. · Starting Pay Rate - $19/hour · **JOB RES ...
-
Outside Sales Representative
5 days ago
SPECTRUM Irvine, KY, United StatesJob Description · Connect people and communities by offering best-in-class telecommunication services through door-to-door solicitation of new prospective customers. · MAJOR DUTIES AND RESPONSIBILITIES · Actively and consistently supports all efforts to simplify and enhance th ...
-
Applied Chemist
26 minutes ago
Diverse Lynx irvine, United States· Job Title: Applied Chemist · Location: Irvine, KY(Remote) · Duration: Fulltime · Job Description:Prepare compounds, test solutions and reagents to conduct tests and experiments, then advising and coordinating on test procedures. · Determine the relationships of chemical and p ...
-
Food Service Director
26 minutes ago
Estill County School District Irvine, United StatesESTILL COUNTY BOARD OF EDUCATION · ADMINISTRATIVE REGULATION - 0070 · JOB DESCRIPTION: Food Service Director · QUALIFICATIONS: · High school diploma with additional undergraduate or vocational training in food service management desired. · Successful prior experience desired in m ...
-
Client Associate
1 week ago
TravisMathew Irvine, United States Part timeTravisMathew is a premium apparel brand that exists because we seized an opportunity-and we're inviting you to take yours. Back in 2007, we saw there weren't many companies whose clothing bridged the gap between performance and lifestyle, so we created our own. Inspired by the su ...
-
Electrical Engineer, Principal
6 days ago
BVI Medical Irvine, United StatesJob Requisition Name Electrical Engineer, Principal Job Requisition No VN7908 Work Location Name USA - Irvine Worker Basis Full Time Worker Type Employee Applications Close Date Company · BVI is refocusing the future of vision. · As one of the fastest-growing, diversified surgi ...
-
AbbVie East Irvine, United States Full time· Company Description · At Allergan Aesthetics, an AbbVie company, we develop, manufacture, and market a portfolio of leading aesthetics brands and products. Our aesthetics portfolio includes facial injectables, body contouring, plastics, skin care, and more. Our goal is to cons ...
-
Senior Systems Engineer I/II
3 weeks ago
AbbVie East Irvine, United States Full time· 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 ar ...
-
Director, Skincare Medical Review Operations
3 weeks ago
AbbVie East Irvine, United States Full time· Company Description · At Allergan Aesthetics, an AbbVie company, we develop, manufacture, and market a portfolio of leading aesthetics brands and products. Our aesthetics portfolio includes facial injectables, body contouring, plastics, skin care, and more. Our goal is to cons ...
-
McTribe Shift Manager
2 weeks ago
McDonald's Irvine, United StatesMcDonald's - 901 RICHMOND RD [Restaurant Shift Lead] As a Shift Manager at McDonald's, you'll: Supervise, manage and motivate team members on a daily basis; Ensure food safety; Perform inventory management and daily maintenance to keep the areas clean; Ensure quality food product ...
-
Food Service Director
1 week ago
Estill County School District Irvine, United StatesESTILL COUNTY BOARD OF EDUCATION · ADMINISTRATIVE REGULATION · JOB DESCRIPTION: · Food Service Director · QUALIFICATIONS:High school diploma with additional undergraduate or vocational training in food service management desired.Successful prior experience desired in manageme ...
-
Mobile Sales
1 week ago
Spectrum Irvine, United StatesAverage Target Compensation of $105,000 + Uncapped IncentivesJOB SUMMARYConnect people and communities by offering best-in-class telecommunication services through door-to-door solicitation of new prospective customers.MAJOR DUTIES AND RESPONSIBILITIESActively and consistently su ...
Senior Scientist I, Biologics Drug Product Development - East Irvine, United States - AbbVie
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 Follow @abbvie onTwitter,Facebook,Instagram,YouTubeandLinkedIn.
Job Description
The incumbent in this role will support the formulation development of protein biologics from early development through commercialization, with a specific focus on neurotoxins for therapeutics and aesthetic use. This position requires laboratory work in areas requiring select agents and Toxins access (i.e. Biosafety level 2 laboratories). Access and use of select agents is highly regulated by federal policies. Therefore, the candidate must conduct all work activities in compliance with AbbVie internal and applicable regulatory requirements. AbbVie internal requirements include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements, and objectives.
Responsibilities