Apogee Therapeutics

Apogee Therapeutics is a biotechnology company focused on research and translational medicine, aiming to develop innovative therapeutic solutions.

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💸 200000 - 225000 USD per year

🔍 Biotechnology

  • Minimum of 12 years industry experience in drug product development and manufacturing.
  • PhD in chemical engineering, biochemical engineering, chemistry, or a related field.
  • Experience in biologics drug product process development and aseptic manufacturing.
  • Experience managing drug product CDMOs including tech transfers and GMP operations.
  • Proven track record of advancing assets from pre-clinical through IND and into late phase development.
  • Extensive experience with cGMPs and knowledge of regulatory guidance.
  • Experience with formulation development of recombinant proteins, including antibodies.
  • Demonstrated ability to collaborate with cross-functional stakeholders.
  • Excellent communication skills and willingness to travel up to 25%.

  • Define and develop robust biologics drug product processes across the portfolio.
  • Oversee drug product manufacturing including tech transfer, process development, and GMP manufacturing operations.
  • Manage drug product CDMO adherence to deliverables, timelines, and performance.
  • Support phase-appropriate strategies for drug product development and commercialization.
  • Collaborate on drug product presentations and development of biologics co-formulations.
  • Perform risk assessments using a QbD approach and identify opportunities for process improvement.
  • Support formulation optimization for injectability and shelf-life.
  • Collaborate with Quality team and external partners to resolve deviations and support investigations.
  • Communicate findings and progress to stakeholders and support regulatory submissions.
Posted 2024-11-13
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🧭 Full-Time

💸 170000 - 190000 USD per year

🔍 Biotechnology

  • S/M.S. degree in Supply Chain Management, Logistics, Pharmaceutical Sciences, or related field.
  • 8-10 years of relevant experience in supply chain management.
  • 3-5 years in a leadership role.
  • Experience in inventory and supply chain management for global clinical trials.
  • Knowledge of ICH guidelines, CFR, and GMP.
  • Strong problem-solving and attention to detail skills.
  • Ability to adapt to a fast-paced environment.

  • Develop and implement clinical supply strategies for multinational programs.
  • Prepare demand forecasts and collaborate with stakeholders to determine demand assumptions.
  • Oversee procurement, labeling, distribution, and return of trial materials.
  • Manage vendor relationships and conduct risk assessments to ensure supply continuity.
  • Maintain inventory systems and ensure compliant distribution to clinical sites.
  • Ensure regulatory compliance and assist in audits.
Posted 2024-11-07
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📍 Arizona, Denver, San Francisco, Los Angeles, Seattle, Nevada

🧭 Full-Time

💸 200000 - 215000 USD per year

🔍 Biotechnology

  • Advanced degree in a relevant medical or scientific field (MD/DO, PharmD, PhD, Master’s degree).
  • Minimum of 3 years of industry experience as a Medical Science Liaison, with expertise in medical dermatology, specifically atopic dermatitis.
  • Strong understanding of clinical study execution and appropriate interactions with clinical study sites.
  • Familiarity with compliance requirements related to medical affairs activities.
  • Knowledge of dermatology treatment paradigms and excellent communication skills.
  • Ability to build and maintain relationships with KOLs and healthcare professionals.

  • Collaborate with clinical study teams to support clinical sites.
  • Develop and maintain relationships with KOLs and clinical study investigators.
  • Act as a scientific resource providing relevant information on development programs.
  • Stay updated on dermatology developments and competitor products.
  • Work with cross-functional teams for strategic alignment and provide feedback.

LeadershipBusiness DevelopmentCross-functional Team LeadershipStrategyBusiness developmentCommunication SkillsAnalytical SkillsCollaboration

Posted 2024-10-21
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📍 Boston, New York, Washington, DC, Tennessee, Georgia, Florida

🧭 Full-Time

💸 200000 - 215000 USD per year

🔍 Biotechnology

  • Advanced degree in a relevant medical or scientific field (MD/DO, PharmD, PhD, Master’s degree, or equivalent).
  • Minimum of 3 years of industry experience as a Medical Science Liaison, specifically in medical dermatology.
  • Strong understanding of clinical study execution and interactions with clinical sites.
  • Knowledge of compliance requirements related to medical affairs.
  • Excellent communication and presentation skills.
  • Ability to build relationships with KOLs and healthcare professionals.

  • Collaborate with clinical study teams to provide medical and scientific support for clinical sites.
  • Develop and maintain relationships with clinical study investigators and key opinion leaders in dermatology.
  • Act as a credible, scientific resource for KOLs regarding Apogee’s development programs.
  • Stay updated on developments in dermatology and competitor products.
  • Work closely with cross-functional teams for strategic alignment.

Communication SkillsAnalytical SkillsCollaboration

Posted 2024-10-21
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🧭 Full-Time

💸 275000 - 295000 USD per year

🔍 Biotechnology

  • BS/BA degree in business or related discipline required; MBA strongly preferred.
  • Minimum of 15 years of relevant experience within the pharmaceutical or biotechnology industry.
  • Specialty launch and pre-launch experience required.
  • Experience in building and leading marketing teams.
  • Highly analytical with strong PowerPoint and communication skills.
  • Ability to synthesize data and deliver key messages.
  • Strong executive presence and comfort presenting to c-suite and board.

  • Build and implement the pre-commercial marketing plan.
  • Conduct market research to identify customer needs.
  • Create preliminary brand plans for products in development.
  • Perform financial analysis and develop digital marketing campaigns.
  • Provide training to cross-functional teams on product and market trends.
  • Partner with various departments to support commercialization efforts.
  • Prepare and present marketing strategy to senior leadership.
Posted 2024-10-21
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🧭 Full-Time

💸 185000 - 205000 USD per year

🔍 Biotechnology

  • PhD in statistics strongly preferred; MS in statistics, biostatistics, or mathematics with relevant experience considered.
  • A minimum of 8 years’ experience in clinical trials.
  • Experience managing CROs and other data vendors.
  • Advanced knowledge in statistical methods and analysis.
  • Ability to communicate complex statistical information to non-statisticians.
  • Proficiency in SAS or R, CDISC standards, and ICH guidelines.

  • Acting as the statistical lead for clinical studies.
  • Providing statistical support on study design and execution.
  • Partnering with cross-functional teams to ensure statistical integrity.
  • Contributing to regulatory submissions and communications with authorities.
  • Overseeing vendor/CRO teams, including verifying results and conducting analyses.
Posted 2024-10-21
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