Pharmacyclics, LLC

Sr. Scientist I

Location
Sunnyvale, CA, United States
Posted
Nov 14, 2018
Ref
2504
Hotbed
Biotech Bay
Required Education
Associate Degree
Position Type
Full time
Pharmacyclics is committed to the development and commercialization of novel therapies intended to improve the quality and duration of life and to resolve serious unmet medical needs for cancer patients. Pharmacyclics is a wholly-owned subsidiary of AbbVie (NYSE:ABBV), a global, research-based biopharmaceutical company. Oncology is a key therapeutic area for AbbVie, with a portfolio consisting of three marketed products and a pipeline containing multiple promising new molecules that are being studied in more than 200 clinical trials for over 20 different types of cancer.

More than 1,200 Pharmacyclics and AbbVie research scientists, clinicians, marketing, operations and corporate professionals work in the San Francisco Bay Area. They combine their expertise in immuno-oncology, stem cells, and cell-signaling with their knowledge of bispecific antibodies, antibody-drug conjugates (ADCs), and covalent-inhibitor technologies to discover and develop novel cancer treatments. Together, we are striving to outsmart cancer.

General Position Summary/Purpose:

Performs synthesis, isolation, and characterization of new chemical entities for the detection and treatment of cancer and autoimmune diseases. Primary assignments include investigation into synthetic reaction pathways towards new chemical entities, development of scalable processes, facilitation of the technology transfer to relevant CMOs, generation of sufficient amounts of compounds of interest to support preclinical studies and Medicinal Chemistry projects as needed, and assistance in the development of lead drug candidates (e.g. identification and generation of impurities, degradation products, and their metabolites). May support CMC efforts for IND/NDA filings and participate on interdisciplinary project teams. Works on complex problems and exercises judgment within broadly defined assignments in selecting methods, techniques, and evaluation criteria for obtaining results. Contributes to the overall R&D program. Communicates results and future plans to the R&D teams.

Major Key Job Duties / Accountabilities / Core Responsibilities: (Include % Time)

Perform laboratory studies to support Chemical Development and Medicinal Chemistry efforts such as:
  • Synthesize up to hundreds of grams of non-GMP APIs and intermediates while identifying route liabilities
  • Generate samples of final API and intermediates to support analytical method development and characterization.
  • Prepare API batches with targeted physical form attributes (ie: amorphous solid dispersions or preferred crystal form) for in-house use
  • Prepare, isolate and characterize process impurities for reference materials
  • Design experiments to understand the mechanism of degradation of investigative products including identification, preparation, and characterization of the degradants.
  • Assist with optimization of current synthetic procedures while scouting alternative routes
  • Assist with technical discussions with contract research and manufacturing organizations working for Pharmacyclics
  • Conduct literature and SciFinder searches to support lab work
  • Perform routine laboratory operations according to company safety procedures and maintain detailed scientific notebook per Pharmacyclics standards

General responsibilities include:

  • Collaborate with departments such as Analytical Chemistry, Medicinal Chemistry, Pharmaceutical Sciences, Global Supply Chain & Logistics, and Facilities
  • Prepare written progress reports and present relevant updates at project team meetings. Reports to be used in technical-transfers, invention disclosures, publications and CMC sections for regulatory submissions ( IND , NDA)
  • May assist in the technical review of master batch records and executed batch records

Qualifications (Knowledge / Skills / Abilities):

  • Strong familiarity with the typical operations of and supporting needs of a synthetic chemistry laboratory
  • Good understanding of organic transformations and mechanisms relevant to small molecules
  • Working knowledge of current Good Manufacturing Practices (cGMPs) a plus
  • Expertise with purification and spectroscopic techniques (NMR, UV-vis, HPLC, TLC)
  • Demonstrated technical proficiency, scientific creativity, collaboration with others and independent thought Experience with technical writing

Specific Skills/Abilities:
  • Strong organizational skills and great attention to detail
  • Ability to conduct multi-step synthetic sequences, perform appropriate purifications, and acquire and interpret relevant analytical data of drug targets and intermediates, all with sound judgment.
  • Excellent verbal and written communication skills, collaborative team player, flexible to change in responsibilities, must be able to communicate effectively with all levels within Department
  • Proficiency with MS Word, Excel, Chem Draw computer programs
  • Must be flexible and able to work well both as part of a team and independently
  • Must be able to make recommendations based on sound logic and data analysis which contribute toward key decisions
  • Hands-on chemistry laboratory experience, including use and maintenance of typical equipment
  • Job may require some heavy lifting and will require proper handling of chemicals

Major Key Job Duties / Accountabilities / Core Responsibilities: (Include % Time)

Perform laboratory studies to support Chemical Development and Medicinal Chemistry efforts such as:
  • Synthesize up to hundreds of grams of non-GMP APIs and intermediates while identifying route liabilities
  • Generate samples of final API and intermediates to support analytical method development and characterization.
  • Prepare API batches with targeted physical form attributes (ie: amorphous solid dispersions or preferred crystal form) for in-house use
  • Prepare, isolate and characterize process impurities for reference materials
  • Design experiments to understand the mechanism of degradation of investigative products including identification, preparation, and characterization of the degradants.
  • Assist with optimization of current synthetic procedures while scouting alternative routes
  • Assist with technical discussions with contract research and manufacturing organizations working for Pharmacyclics
  • Conduct literature and SciFinder searches to support lab work
  • Perform routine laboratory operations according to company safety procedures and maintain detailed scientific notebook per Pharmacyclics standards

General responsibilities include:
  • Collaborate with departments such as Analytical Chemistry, Medicinal Chemistry, Pharmaceutical Sciences, Global Supply Chain & Logistics, and Facilities
  • Prepare written progress reports and present relevant updates at project team meetings. Reports to be used in technical-transfers, invention disclosures, publications and CMC sections for regulatory submissions ( IND , NDA)
  • May assist in the technical review of master batch records and executed batch records

Qualifications (Knowledge / Skills / Abilities):

Knowledge:
  • Good understanding of organic transformations and mechanisms relevant to small molecules
  • Familiarity with manufacturing-scale equipment, processes, and procedures, as well as working knowledge of current Good Manufacturing Practices (cGMPs) pluses
  • Expertise with purification and spectroscopic techniques (NMR, UV-vis, HPLC, TLC)
  • Demonstrated technical proficiency, scientific creativity, collaboration with others and independent thought
  • Experience with technical writing

Specific Skills/Abilities:
  • Strong organizational skills and great attention to detail
  • Ability to conduct multi-step synthetic sequences, perform appropriate purifications, and acquire and interpret relevant analytical data of drug targets and intermediates, all with sound judgment.
  • Excellent verbal and written communication skills, collaborative team player, flexible to change in responsibilities, must be able to communicate effectively with all levels within Department
  • Proficiency with MS Word, Excel, PowerPoint, and Chem Draw computer programs
  • Must be flexible and able to work well both as part of a team and independently
  • Must be able to make recommendations based on sound logic and data analysis which contribute toward key decisions
  • Job may require some heavy lifting and will require proper handling of chemicals

Management: (Include old & new org chart)

  • Potential personnel management responsibilities for this position as group expands

Nature of Contacts (Internal & External):

  • Will typically interact daily with lab-based personnel from both Tech Ops (specifically Chemical Development, Analytical Chemistry, and Pharmaceutical Sciences) and Medicinal Chemistry (up through seniority level of Director/Principal Scientist)
  • Will likely have interactions with more senior (Senior Directors and above) members of Tech Ops on a regular basis
  • Will have varying interactions with Associates and Managers within Global Supply Chain and Logistics, Shipping and Receiving, EH&S, Facilities, IT, and Procurement

Decision Making Authority / Discretion:

  • Will independently conduct scientific experiments, make decisions and/or recommendations on next steps
  • May independently procure quotes for equipment, services, and large specialty chemical orders for supervisor and group review

Experience:

  • 5+ years of relevant lab experience, including demonstrated background in synthetic organic chemistry and hands-on experience of working with and maintenance of typical laboratory equipment
  • Hands-on process development and scale-up experience a plus

Education Requirements (degree, certifications, etc.): Include must have and preferred

  • BS/BA in Chemistry required with 5-10 years prior lab experience in a Biotech/Pharma setting required
  • Ph.D in Synthetic Organic Chemistry with 1-5 years relevant experience preferred

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