Senior Scientist, Process Development

Brisbane, CA

Perm Salary

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OVERVIEW

We are currently searching for a skilled professional to join a well-known client’s team as an Senior Scientist. Their work will have a direct impact on not just the organization but the larger clinical industry making this an amazing career opportunity. 

RESPONSIBILITIES

  • Primary responsibility includes guiding the process development activities at different contract development and manufacturing organizations (CDMO)
  • Strong networking within cross functional teams, strengthening and assuring the scientific knowledge/expertise at the CDMO, innovation, customer focus and teamwork, and ensuring control strategies and processes which align with regulatory expectations and project goals
  • Authoring and reviewing regulatory dossiers for submission and development reports
  • Ability to work independently and as an effective and engaged team member in a fast-paced environment. Strong initiative and follow through are essential for this job
  • Maintain confidentiality and to operate in the role with the highest of ethical standards and professionalism
  • Participate as a core member of the PDM team and lead the drug product development efforts along with associated clinical manufacturing activities
  • Ensure development and execution of project plans including milestones, timelines, resources and budgets
  • Create process development and API manufacturing strategies, scope, and work plans to be executed at CDMO
  • Oversee the execution of development activities, API manufacturing and other project deliverables at CDMO
  • Monitoring and communicating progress and quality of development, technical transfer and production activities, and taking appropriate actions
  • Review documents from CDMO including development reports, batch production records, analytical data packages, stability data
  • Ensure overall compliance with regulatory requirements, GMP guidelines and EHS practices

REQUIREMENTS

  • Thorough understanding of synthetic organic chemistry and process development for small molecules
  • Three plus years of experience in the pharmaceutical/biotech industry, GMP environment
  • Deep knowledge and modern practices of process development, GMP principles, ICH guidelines, with wide-ranging experiences and understanding of small molecule drug development and manufacturing are requirement
  • Significant experience in working with external resources as well as collaborating internal teams
  • Strong track record of scientific achievements including publications and presentations
  • Candidates should have advanced problem-solving skills, strategic thinking, ability to work in a team environment and outstanding written and verbal communication skills
  • Regularly required to operate standard office equipment
  • Ability to work on a computer for extended periods of time
  • Regularly required to sit for long periods of time, and occasionally stand and walk
  • Regularly required to use hands to operate computer and other office equipment
  • In-depth knowledge and hands-on experience with GMP operations, manufacturing process and production equipment
  • Travel up to 15%

EDUCATION

  • Ph.D in Organic Chemistry, or M.S. degree in Chemistry with relevant industry experience

To be a best-fit your strengths must include

  • Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology 
  • Organized. You’re an efficient time-manager and can handle the pressure of meeting multiple strict deadlines 
  • Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure 
  • Problem-Solvers.  As an action-oriented self-starter, you’re eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges
  • Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objective.   
  • Credible. Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource  

About Advanced Clinical

Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune’s Top Workplaces, Chicago’s Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.

Regarding your application

Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.

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