Talent.com
Director-PK/ADA-Biologics Services
Director-PK/ADA-Biologics ServicesFrontage Laboratories, Inc • Exton, PA, US
serp_jobs.error_messages.no_longer_accepting
Director-PK / ADA-Biologics Services

Director-PK / ADA-Biologics Services

Frontage Laboratories, Inc • Exton, PA, US
job_description.job_card.variable_days_ago
serp_jobs.job_preview.job_type
  • serp_jobs.job_card.full_time
job_description.job_card.job_description

Director / Sr. Director-Biologics (PK-ADA)

Location : Exton, PA

Full-time

Frontage Laboratories Inc. is an award winning, full-service, CRO / Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada and China. Our core competencies include drug metabolism, pharmacokinetics / pharmacodynamics (PK / PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials.

Responsibilities

  • Lead a group of scientists for PK / TK, immunogenicity (ADA, Nab) method development, validation and sample analysis in the regulated environment.
  • Manage all the projects within the Biologics Department on daily basis to ensure the quality, timeline and deliverable are met.
  • Provide strong technical support to the team on different assay formats. Ability to trouble-shoot and solve technical issues.
  • Review bioanalytical documentation that includes study protocols, method validation plan, sample analysis plans, data packages, validation study reports and sample analysis reports.
  • Act as the main point of contact for biologics projects, discuss the projects with clients, and provide timely communication and updates internally and externally.
  • Train staff on laboratory procedures, documentation and GLP compliance.
  • Write and update SOPs. Maintain GLP compliant PK and immunogenicity Labs.
  • Provide technical support to Frontage PK and immunogenicity Labs in China when needed.
  • Support Business Development including reviewing proposals and meeting with new clients.

Requirements

  • PhD in Biology or Chemistry, or related field with experience managing a group of scientists.
  • Hands-on experience in ligand binding assays, especially PK and ADA, method development.
  • Strong experience and knowledge of method development / validation for supporting regulated studies
  • Excellent communication and interpersonal skills and project management skills.
  • Salary And Benefits

    Frontage Laboratories offers a competitive compensation and benefits package including health and dental insurance, a 401(k) plan, disability insurance, and life insurance

    Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.

    serp_jobs.job_alerts.create_a_job

    Service • Exton, PA, US

    Job_description.internal_linking.related_jobs
    Sr Director Clinical Research Scientist IAI

    Sr Director Clinical Research Scientist IAI

    Incyte Corporation • Wilmington, DE, United States
    serp_jobs.job_card.full_time
    Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmuni...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Director, HEOR IAI

    Director, HEOR IAI

    Incyte Corporation • Chadds Ford, PA, United States
    serp_jobs.job_card.full_time
    Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmuni...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Director of Clinical Strategy

    Director of Clinical Strategy

    VirtualVocations • Newark, Delaware, United States
    serp_jobs.job_card.full_time
    A company is looking for a Director, Clinical Strategy & Operations.Key Responsibilities Lead and develop a high-performing team focused on forecasting, scheduling, and productivity optimization ...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Assoc. Director, Thought Leader Liaison, East Region

    Assoc. Director, Thought Leader Liaison, East Region

    Incyte Corporation • Wilmington, DE, United States
    serp_jobs.job_card.full_time
    Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmuni...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Product Director - Agriculture Technology

    Product Director - Agriculture Technology

    VirtualVocations • Newark, Delaware, United States
    serp_jobs.job_card.full_time
    A company is looking for a Product Director - Labor Management & Field Operations.Key Responsibilities Define and execute the product strategy for labor tracking, workforce management, and field ...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_1_day • serp_jobs.job_card.promoted
    Associate Director / Director, Clinical & Quantitative Pharmacology

    Associate Director / Director, Clinical & Quantitative Pharmacology

    Incyte Corporation • Wilmington, DE, United States
    serp_jobs.job_card.full_time
    Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmuni...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Director / Senior Director, Clinical Research Scientist

    Director / Senior Director, Clinical Research Scientist

    Incyte Corporation • Wilmington, DE, United States
    serp_jobs.job_card.full_time
    Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmuni...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    RN Clinical Director

    RN Clinical Director

    Berkshire Eye Surgery Center (13460) • WYOMISSING, Pennsylvania, United States
    serp_jobs.job_card.full_time
    Berkshire Eye Surgery Center is hiring a RN Clinical Director!.At Berkshire Eye Surgery Center, we believe health and care are inseparable. We focus on offering a high quality, service oriented envi...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Director of Clinical Pharmacology

    Director of Clinical Pharmacology

    VirtualVocations • Newark, Delaware, United States
    serp_jobs.job_card.full_time
    A company is looking for a Director, Clinical Pharmacology to lead clinical pharmacology strategy in drug development.Key Responsibilities Lead clinical pharmacology strategy across early- and la...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Sr. Manager, Biologics CMC Writer

    Sr. Manager, Biologics CMC Writer

    Incyte Corporation • Wilmington, DE, United States
    serp_jobs.job_card.full_time
    Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmuni...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Director of Life Sciences Sales

    Director of Life Sciences Sales

    VirtualVocations • Newark, Delaware, United States
    serp_jobs.job_card.full_time
    A company is looking for a Director of Solution Sales - Life Sciences.Key Responsibilities Prospect for new accounts based on industry intelligence and proactive networking Qualify inbound leads...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_hours • serp_jobs.job_card.promoted • serp_jobs.job_card.new
    Director, Global Product Strategy, Inflammation & Autoimmunity

    Director, Global Product Strategy, Inflammation & Autoimmunity

    Incyte Corporation • Wilmington, DE, United States
    serp_jobs.job_card.full_time
    Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmuni...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Sr. Director, Company Sponsored Trials

    Sr. Director, Company Sponsored Trials

    Incyte Corporation • Chadds Ford, PA, United States
    serp_jobs.job_card.full_time
    Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmuni...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Oncology Business Director, MPN Mid Atlantic

    Oncology Business Director, MPN Mid Atlantic

    Incyte Corporation • Wilmington, DE, United States
    serp_jobs.job_card.full_time
    Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmuni...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Associate Director, Biostatistics

    Associate Director, Biostatistics

    Incyte Corporation • Wilmington, DE, United States
    serp_jobs.job_card.full_time
    Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmuni...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Associate Director, Global Clinical Supply Chain

    Associate Director, Global Clinical Supply Chain

    Incyte Corporation • Wilmington, DE, United States
    serp_jobs.job_card.full_time
    Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmuni...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Director / Senior Director, Oncology (MPN) HCP Lead

    Director / Senior Director, Oncology (MPN) HCP Lead

    Incyte Corporation • Chadds Ford, PA, United States
    serp_jobs.job_card.full_time
    Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmuni...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    US Regulatory Policy Director

    US Regulatory Policy Director

    VirtualVocations • Newark, Delaware, United States
    serp_jobs.job_card.full_time
    A company is looking for a Director, US Regulatory Intelligence & Policy Lead.Key Responsibilities Lead the acquisition, analysis, communication, and management of US regulatory intelligence Dev...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Associate Director / Director, Study Trial Master File

    Associate Director / Director, Study Trial Master File

    Larimar Therapeutics • Bala-Cynwyd, PA, US
    serp_jobs.job_card.full_time
    Associate Director / Director, Study Trial Master File (TMF) .Chief Development Officer (initially).Our lead product candidate, Nomlabofusp (CTI-1601), is a subcutaneously administered, recomb...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Sr. Manager / Associate Director, US Medical Information - Dermatology / IAI

    Sr. Manager / Associate Director, US Medical Information - Dermatology / IAI

    Incyte Corporation • Chadds Ford, PA, United States
    serp_jobs.job_card.full_time
    Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmuni...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted