Senior Principal Research Scientist

Initial Therapeutics, Inc.; Irvine (CA); On-site; USD 130,000 - 180,000; Full time

Job summary

A leading global biopharmaceutical company seeks a Director for oral Peptides to oversee process research and formulation development. Candidates must possess strong analytical skills and relevant educational qualifications, aiming to drive innovation and cross-functional collaboration in drug development.

Benefits

Paid time off including vacation

Medical, dental, and vision insurance

401(k) program

Participation in incentive programs

Qualifications

• Minimum 10+ years related industry experience for PhD holders.
• Proven scientific leadership and interpersonal skills.
• In-depth experience with analytical techniques like HPLC, SEC.

Responsibilities

• Lead analytical teams for peptide drug development.
• Develop regulatory strategies and submissions.
• Mentor scientific staff and foster collaboration.

Skills

Analytical techniques for peptide characterization

Interpersonal and communication skills

Regulatory strategy development

Problem-solving skills

Education

PhD in Analytical Chemistry

Masters in Analytical Chemistry

Bachelors in Analytical Chemistry

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

AbbVie (NYSE:ABBV) is a global, research-based biopharmaceutical company formed in 2013, following separation from Abbott. AbbVie combines the focus and passion of a leading-edge biotech with the expertise and capabilities of a long-established pharmaceutical leader, to develop and market advanced therapies that address some of the world's most complex and serious diseases. AbbVie employs approximately 50,000 people worldwide and markets medicines in more than 170 countries. Analytical Research and Development is seeking a Director (oral) Peptides to conduct process research and formulation development of parenteral and oral macrocyclic peptides from pre-clinical through early clinical phases.

Key Responsibilities:

• The candidate will lead analytical teams associated with drug substance and drug product development and characterization of peptides and other modalities.
  • Leverage prior experience leading analytical efforts focused on phase appropriate peptide drug substance and drug product development.
  • Experience developing global regulatory strategies including authoring regulatory submissions, and responding to regulatory questions across global markets.
  • Lead across functions within project teams to deliver robust control strategies for starting materials, intermediates, drug substances and drug products.
  • Proactively drives innovation by leveraging external networks, industry insights, and prior experiences to identify emerging trends, foster strategic partnerships, and implement forward-thinking solutions.
  • Responsible for fit-for purpose method development, testing procedures, justifying specifications, and implementation of analytical control strategies to help the advancement of candidate molecules.
  • Proactively advise and share knowledge and expert opinions with subordinates, peers, and senior management.
  • Mentor and develop scientific staff in troubleshooting strategic and experimental issues and foster a culture of knowledge sharing.
• The position involves multi-disciplinary collaborations across Discovery, Development, Manufacturing, and Regulatory to execute and deliver material and information for clinical trials and regulatory submissions.
• The candidate will identify and nurture ideas for continuous improvement activities and initiatives within the department.
• This role may include management of direct reports.

Qualifications

• Bachelors, Masters, or PhD in Analytical Chemistry with a minimum of 18+ (B.S.), 16+ (M.S.), or 10+ (Ph.D.) years of related industry experience (advanced degree in Analytical Chemistry preferred)Experience with analytical aspects of advancing peptide modalities.
• Proven scientific leadership; strong interpersonal and communication skills for facilitating collaborations and a demonstrated ability to represent analytical in cross-functional development teams.
• In depth experience with analytical techniques required for peptide characterization, such as HPLC, SEC, chiral, amino acid analysis, peptide content, impurity identification, peptide mapping etc.
• Demonstrated leadership of technical teams and effective cross-functional communication

• Demonstrated capability to solve critical scientific and business problems

• Demonstrated ability to implement and to grow the capabilities of an analytical organization and develop scientists into future leaders

• Demonstrated experience with global regulatory expectations and regulatory filings in the peptide space.

Key AbbVie Competencies:

Interacts well with diverse groups within function and maintain strong working relationships with internal and external collaborators to enable higher performance.

• Learns fast, grasps the "essence" and can change course quickly where indicated.
• Raises the bar and is never satisfied with the status quo.
• Creates a learning environment, open to suggestions and experimentation for improvement.
• Embraces the ideas of others, nurtures innovation and manages innovation to reality.

Level and compensation will be commensurate with experience.

Additional Information

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

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

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

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

• This job is eligible to participate in our long-term incentiveprograms

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