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Senior Manager, Drug Product Formulation Development

Company: Spero Therapeutics
Location: Cambridge
Posted on: April 4, 2021

Job Description:

Senior Manager, Drug Product Formulation Development Spero Therapeutics (Nasdaq: SPRO) is a multi-asset clinical stage biopharmaceutical company in Cambridge, Mass. We are highly committed to advancing novel treatment approaches for bacterial infections with a world-class team of biotechnological and biopharmaceutical experts. The company has a pipeline of novel and highly differentiated antibacterial and rare disease product candidates focused on the unmet needs of patients with multi-drug resistant (MDR) bacterial infections. Spero's lead product candidate, Tebipenem HBr, is an oral carbapenem currently being evaluated in a pivotal Phase 3 clinical trial for the treatment of complicated urinary tract infections. Spero is also advancing SPR720, its oral antimicrobial agent in development for the treatment of nontuberculous mycobacterial (NTM) pulmonary disease, a rare orphan disease. Spero's third product candidate, SPR206, is an IV-administered agent being developed as an innovative option to treat MDR Gram-negative bacterial infections. We sincerely believe that our novel product candidates will have meaningful impact on patient health and significant commercial applications for the treatment of MDR infections in both the hospital and community settings. General Scope and Summary of Role Spero Therapeutics is looking for a collaborative, enthusiastic, self-starting partner responsible for formulation development and manufacture of early phase drug product (DP) for Spero's small molecule NCEs in clinical development. Focusing on formulation development of oral solid dosage (OSD) presentations, the individual will work in a cross functional CMC team environment with colleagues from drug substance, analytical development, QA, Supply Chain, and DP MS&T to plan, coordinate, and execute DP development strategies and ensure timely manufacturing to support clinical DP supply. In addition, the successful candidate will collaborate to study critical formulation and process parameters, perform scale-up studies and technology transfers, troubleshoot process related issues and contribute to root cause analysis for manufacturing deviations and investigations. The Manager will also ensure that drug product development and clinical supply timelines are met and will contribute support to regulatory CMC filings.
-- What You'll Do

  • Manage formulation development and clinical manufacturing activities at external laboratories and manufacturing facilities.
  • Lead product development to conventional dosage form suitable for late stage manufacturing and validation (tablet, powder filled capsule, etc)
  • Responsible for managing pre-formulation, formulation development, delivery of clinical supplies, development of efficient and scalable manufacturing processes.
  • Design and Initiate stability studies on selected batches of products
  • Evaluate relevant characteristics of raw materials and experimental batches in an effort to develop robust manufacturing practices
  • Perform product/process validation when required; including designing procedures, overseeing batch sampling, and analyzing data
  • Coordinate with Analytical Department for completing testing of new drug products in a timely manner, and developing appropriate control strategies
  • Implement drug product process evaluation and manufacturing activities in accordance with documented work plans and/or cGMP requirements.
  • Document preparation related to GMP operations as requested and appropriate.
  • Oversee the implementation and/or technology transfer of drug product processes and process improvements into CMOs.
  • Monitor deviations and process/operational changes; ensure appropriate technical and management visibility within Spero to these events and facilitate feedback and decisions to the CMOs.
  • Work closely with broader CMC and program teams to ensure on time delivery of drug product.
  • Works collaboratively and transparently with Quality Assurance and Regulatory Affairs to ensure a high-quality level of cGMP.
  • Coordinate technology transfers to ensure effective information flow, timeline execution, issue resolution, and documentation for cross-functional teams.
  • Make decisions, based on the professional judgment, experience, budget, cGMP regulations, and the ethical guidelines of good business practices. What You'll Need--
    • BS/MS degree in Pharmaceutics, Chemistry, Chemical Engineering, or comparable scientific degree with 5+ years of experience in the Biotech or Pharmaceutical industry focused on small molecule drug product development and manufacturing
    • PhD with 2-5 + years of experience in the Biotech or Pharmaceutical industry focused on early phase small molecule drug product development and manufacturing.
    • A proven track record in developing and scaling up formulations for oral administration from pre-IND through late stage development.
    • Extensive hands-on experience in the development and clinical manufacturing environment towards the development of oral solid dosage.
    • Direct experience developing and screening formulations for early phase clinical supply.
    • Familiarity with evaluating formulation compatibility, optimization and solid-state characterization - microscopy, X-ray diffraction, thermal analysis, solid-state NMR, moisture sorption
    • Familiarity with API physiochemical characterization, powder flow evaluation and characterization
    • Experience in developing immediate, modified and controlled release formulations and dosage forms.
    • Experience developing associated pediatric formulations
    • Proficiency with Quality by Design (QbD) concepts and design of experiments (DoE) required.
    • Familiarity with a contract manufacturing environment with an in-depth knowledge of small molecule drug product unit operations, impact of process parameters, in-process characterization techniques, process development, and principles of cGMP is a plus.
    • Experience as primary author of relevant sections of INDs
    • Established and demonstrated experience in using a wide variety of formulation concepts across multiple development programs to deliver to a project's Target Product Profile; experience in formulation or process technologies to employ enabling formulation technologies or unique delivery systems is desirable.
    • Hands-on, can-do individual with a collaborative personal style and the ability to work well in a fast-moving team/collaborative environment.
    • Experience with aseptic processing, sterile manufacturing a plus but not required.
    • Ability to effectively work independently and in a team environment
    • Ability to travel up to 25% of the time. By joining our committed and highly motivated team, you'll experience a workplace culture that is inclusive, fair, challenging, supportive, and respectful. Spero's culture is one that emphasizes "servant leadership," or putting ego aside and working for the benefit of the team and our patients and values our colleagues' opinions and celebrates accomplishments in service of patients. What's your citizenship / employment eligibility?* LinkedIn Profile URL: Desired salary* The following questions are entirely optional. To comply with government Equal Employment Opportunity and/or Affirmative Action reporting regulations, we are requesting (but NOT requiring) that you enter this personal data. This information will not be used in connection with any employment decisions, and will be used solely as permitted by state and federal law. Your voluntary cooperation would be appreciated. Learn more . Invitation for Job Applicants to Self-Identify as a U.S. Veteran
      • A "disabled veteran" is one of the following:
        • a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or
        • a person who was discharged or released from active duty because of a service-connected disability.
        • A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.
        • An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.
        • An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985. I IDENTIFY AS ONE OR MORE OF THE CLASSIFICATIONS OF PROTECTED VETERAN LISTED ABOVE
          I AM NOT A PROTECTED VETERAN
          I DON'T WISH TO ANSWER Voluntary Self-Identification of Disability Voluntary Self-Identification of Disability Form CC-305
          OMB Control Number 1250-0005
          Expires 5/31/2023 Why are you being asked to complete this form? We are a federal contractor or subcontractor required by law to provide equal employment opportunity to qualified people with disabilities. We are also required to measure our progress toward having at least 7% of our workforce be individuals with disabilities. To do this, we must ask applicants and employees if they have a disability or have ever had a disability. Because a person may become disabled at any time, we ask all of our employees to update their information at least every five years. Identifying yourself as an individual with a disability is voluntary, and we hope that you will choose to do so. Your answer will be maintained confidentially and not be seen by selecting officials or anyone else involved in making personnel decisions. Completing the form will not negatively impact you in any way, regardless of whether you have self-identified in the past. For more information about this form or the equal employment obligations of federal contractors under Section 503 of the Rehabilitation Act, visit the U.S. Department of Labor's Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp . How do you know if you have a disability? You are considered to have a disability if you have a physical or mental impairment or medical condition that substantially limits a major life activity, or if you have a history or record of such an impairment or medical condition. Disabilities include, but are not limited to:
          • Autism
          • Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, or HIV/AIDS
          • Blind or low vision
          • Cancer
          • Cardiovascular or heart disease
          • Celiac disease
          • Cerebral palsy
          • Deaf or hard of hearing
          • Depression or anxiety
          • Diabetes
          • Epilepsy
          • Gastrointestinal disorders, for example, Crohn's Disease, or irritable bowel syndrome
          • Missing limbs or partially missing limbs
          • Nervous system condition for example, migraine headaches, Parkinson's disease, or Multiple sclerosis (MS)
          • Psychiatric condition, for example, bipolar disorder, schizophrenia, PTSD, or major depression Please check one of the boxes below: YES, I HAVE A DISABILITY, OR HAVE A HISTORY/RECORD OF HAVING A DISABILITY NO, I DON'T HAVE A DISABILITY, OR A HISTORY/RECORD OF HAVING A DISABILITY I DON'T WISH TO ANSWER PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.

Keywords: Spero Therapeutics, Cambridge , Senior Manager, Drug Product Formulation Development, Executive , Cambridge, Massachusetts

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