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Boehringer Ingelheim jobs in Athens, GA - 66 jobs

  • Technician III, Packaging Athens (10:30pm-7:00am)

    Boehringer Ingelheim 4.6company rating

    Boehringer Ingelheim job in Athens, GA

    Effectively and efficiently operates packaging and labeling equipment in order to package quality products per BI's Standards and in compliance with the USDA. As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees. **Duties & Responsibilities** + Adhere to Standard Operating Procedures to set up and operate Packaging equipment (Printers, Coders, Labelers, Vision systems, Tray assemblers, Heat tunnels, Dryers, Forklift, Storage units, etc.) + Accurately perform and complete all documentation require to request all packaging products, materials and components require for the day to day operations of the packaging department. + Maintain all waste materials in the proper satellite storage bins. + Accurately perform reconciliations within the batch records and oracle transactions of products, materials, and components used in packaging. + Effectively and efficiently troubleshoot packaging equipment in order to package quality products per standard operating procedures. + Effectively provide/report information on process deviations. + Train others as assigned/needed. + Observe, challenge, advise, and support teammates to adhere to policies and/or procedures. + Effectively communicate process and/or equipment needs. + Data entry which includes recording product packaging information, downtime, and standard production yields. + Maintains a safe, clean and organize work environment. + Maintains facilities and equipment as required by Standard Operating Procedures. **Requirements** + B.S. Biology or related field from an accredited institution and two (2) years of relevant experience. + High school diploma or equivalent and five (5) years of relevant experience. + High school diploma or equivalent and seven (7) years relevant experience preferred. + Twelve (12) months of manufacturing experience. + Equipment troubleshooting knowledge and skills. + Ability to follow detailed instructions and procedures. + Ability to lift up to 35 lbs. + Ability to operate a reach truck forklift. + Basic aptitude for math and computer skills. + Manufacturing experience, preferably in a packaging/labeling operation. + Basic Computer Skills (example: MS Outlook and web-based applications). + Basic ERP system knowledge (example: Oracle, SAP, etc.). + Basic mechanical skills (example: use of basic tools). **Desired Skills, Experience and Abilities** All qualified applicants will receive consideration for employment without regard to a person's actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.
    $38k-45k yearly est. 33d ago
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  • Principal Specialist, QA

    Boehringer Ingelheim 4.6company rating

    Boehringer Ingelheim job in Athens, GA

    As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees. The Principal Specialist, QA provides support at the GI site to ensure the integrity and compliance of GI outputs intended for regulatory submissions. This role supports the Site Quality Head (SQH) to ensure that the site is ready for GxP regulatory inspections. **Duties & Responsibilities** + Supports Deviations, Investigations and CAPA Process, and change controls opened and their potential impact. + Participates in working groups aiming at harmonizing and improving QS processes and/or serves as local GIQA project representative on Q projects. + Ensures GMP compliance during project development phases at local level. + Ensures the QA review of GMP study documents or GMP GI batch production documents that will be required for the registration and/or validation of methods developed by GI to ensure GMP compliance. Local Inspections and Audits: + Participates in the organization, execution and follow up of GxP inspections and audits. Inspections and audits may include internal audits of GI facilities and systems for compliance with international regulatory directives and corporate, divisional, and departmental policies and procedures. + Supports the follow-up of CAPA plan. + Conducts third party audits for local suppliers. + Where applicable, conduct in-process GCP/GLP audits (e.g., critical phase inspections, investigate site audits or similar) and prepare reports within defined timelines. + Depending on gained experience, may also lead fewer complex audits. + May serve as local management system owner (LMSO) for supplier qualification at the respective site. Documentation: + Provides QA review for local quality system document. + Reviews and approves as QA the necessary procedures in place to cover GI GxP activities (e.g., SOP, specifications). + Ensures compliance of facilities and equipment by reviewing the appropriate documentation (e.g., validation, logbook, qualification report, ...). Training: + Supports the conduct of training to GI personnel to ensure knowledge of regulations, guidelines, and standard operating procedures. + If required, also supports conduct of other quality training as per identified needs. + Depending on gained experience, may also conduct training of GI personnel. Process Improvement: + Supports identification of opportunities for improvements as well as gains approval for and implement quality improvements. + Provides timely and accurate reporting of appropriate measures of quality performance to GI management (e.g., KPIs, QMRs). **Requirements** + BA/BS in chemistry, life sciences, pharmacy or a related field or equivalent education with minimum of five (5) years' professional experience in a relevant domain. + Three (3) years prior experience conducting audits as auditor or comparable experience as auditee in the pharmaceutical, biological or equivalent industry. + Experience conducting audits in the pharmaceutical, biological, or equivalent industry. + Ability to work in a project team environment. + Rigor, autonomy, organization in the work, ability to work in a team, good interpersonal skills, proactivity, strength of conviction. + Good understanding in working in cross-functional projects and environments. + Excellent communication skills in local language (spoken and written), good communication skills in English. + Good knowledge in GxP. + General understanding of quality assurance and quality management. Experience in supporting internal audits. + Excellent verbal and written communication skills. + Skillful in using office application software (MS-Word, MS-Excel, MS-Outlook). **Eligibility Requirements** : + Must be legally authorized to work in the United States without restriction. + Must be willing to take a drug test and post-offer physical (if required). + Must be 18 years of age or older. All qualified applicants will receive consideration for employment without regard to a person's actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.
    $59k-78k yearly est. 3d ago
  • Pharmaceutical Sales- Associate Territory Manager- Cardiometabolic Health

    Eli Lilly and Company 4.6company rating

    Athens, GA job

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Territory position- ATHENS, GA CMH1_170275 At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. The Territory Manager will be accountable for account-based selling to health care providers (HCPs) who prescribe and influence the treatment for the disease states represented in the Lilly portfolio. This includes customers in multiple HCP specialties, as well as representatives in key hospital accounts. They will be viewed as a credible expert and resource supporting all medicines and appropriate brand patients. The Territory Manager will be accountable for driving results by embracing Lilly's suite of models: Lilly Selling Model, Lilly Competency Model and Account Management Model to meet the needs of customers through strong execution. Territory Managers will drive consistent ways of working within the Regional Healthcare Market. They will build relationships with key customers to drive utilization and adoption of our medicines for the right patients. Specific responsibilities include the following: BUSINESS OWNERSHIP · Promotes the full portfolio of priority products with multiple HCP specialties. · Understands the marketplace within the territory; evaluates and tailors the territory strategy to grow and own business outcomes. · Navigates the ever-changing healthcare environment and payer landscape to increase understanding of accounts and be able to impact key stakeholders to become trusted partners. · Utilizes appropriate business insight tools, data, and analytics to identify trends, priorities, opportunities, and potential obstacles. · Implements and adopts new technologies, including the integration of AI company-approved tools and other analytical capabilities to streamline customer interactions. · Identifies and advocates for new opportunities to enhance the customer experience. · Models a growth mindset to create positive experiences. SELLING SKILLS / CUSTOMER EXPERIENCE · Embraces and uses the company's selling, competency and account management models to elevate performance and drive results. · Demonstrates high learning agility to understand disease state, marketplace, clinical trials, and product label. · Promotes the BU portfolio by planning for and engaging in patient-centered dialogues with customers. EXECUTION / RESULTS · Promotes across BU-portfolio and across HCP specialties, driving consistent ways of working within the Regional Health Care Market to meet customers' needs. Appropriately, fully utilizes the Virtual Medical Hub. · Achieves targeted sales and execution metrics while adhering to company policies and procedures. · Owns the customer relationship for product promotion, on-label medical questions, and general market access. · Holds self-accountable for results and performance across all accounts, from individual HCPs to large health systems. · Builds and maintains relationships with both internal and external partners to foster trust and create collaborative success. BASIC QUALIFICATIONS · Bachelor's degree. · Professional certification or license required to perform this position if required by a specific state. · Valid driver's license and acceptable driving record. · Legally authorized to be employed in the United States. ADDITIONAL SKILLS / PREFERENCES · Demonstrated business ownership skills, selling/customer experience skills, and execution/results. · Account based selling experience. Ability to identify and engage staff members in accounts. · Strong learning agility, self-motivated, team focused, and emotionally intelligent. · Bilingual skills as aligned with territory and customer needs. · Residence within 30 miles of the territory boundary. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $63,000 - $151,800 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly
    $63k-151.8k yearly Auto-Apply 7d ago
  • SR Principal Specialist, BPE

    Boehringer Ingelheim 4.6company rating

    Boehringer Ingelheim job in Athens, GA

    As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees. The Senior Principal Specialist, BPE will lead a team to develop and embed skills and behaviors across the business to establish a sustainable continuous improvement (CI) culture within Boehringer Ingelheim. The incumbent will drive measurable business improvements through collaboration, leadership, communication, analytics, and other tools. **Duties & Responsibilities** + Engages, coaches, and mentors BIAH leaders, process owners, and value adders to develop and deploy the Boehringer Ingelheim Business Process Excellence strategic plan to drive attainment of the organizations vision. + Identifies, prioritizes and gains buy-in for projects to drive improvements through the hierarchy of People, Delivery, Quality, Cost, and Safety which aligns with BIAH's strategic goals and objectives. + Establishes a continuous improvement (CI) philosophy, to create accountability and ownership. + Designs, develops, and delivers CI training and tools to all levels of the organization. + Models advanced problem-solving and BPE Leadership behavior and propagates that behavior throughout the organization. + Networks and collaborates with Global and Regional BPE Leaders to share best practices. **Requirements** + Bachelor's Degree required, a focus in Biology or another life sciences field preferred; Master's Degree, preferred. + Six (6) years progressive team leadership and project management experience. + Professional Training: Six Sigma Black Belt certification required, Lean Six Sigma Master Black Belt and Lean Manufacturing Certifications preferred. + Experience with advanced problem-solving (LEAN Six Sigma) and change-management methodologies consistent with establishing a culture of continuous improvement required. + Should be able to demonstrate project / program ROI results from previous experience. + Exemplary interpersonal, verbal, and written communication skills; able to communicate effectively and interact with personnel at all levels of the organization. + Must be a results-oriented Change-Agent; a skilled facilitator adept to influence, negotiation, and conflict resolution with a demonstrated ability to lead by influence and drive results without direct authority. + Ability to work under deadlines and handle multiple and detail-oriented tasks. + Experience applying Continuous Improvement (LEAN, Six Sigma, project management) techniques in a vaccine manufacturing and business environment preferred. + Experience with data collection and reporting. + Proficient in Microsoft Office Tools: Excel, Access, Word, PowerPoint, Visio, and statistical analysis software. (e.g., Minitab, JMP, etc.) **Eligibility Requirements** : + Must be legally authorized to work in the United States without restriction. + Must be willing to take a drug test and post-offer physical (if required). + Must be 18 years of age or older. **Desired Skills, Experience and Abilities** All qualified applicants will receive consideration for employment without regard to a person's actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.
    $104k-134k yearly est. 48d ago
  • AD, Reg Affairs Service Center

    Boehringer Ingelheim 4.6company rating

    Boehringer Ingelheim job in Athens, GA

    As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees. The Associate Director, RA Service Center will hold full accountability for the Regulatory Affairs (RA) US outsourcing program, ensuring its successful execution and further development in alignment with the company's strategic plan. The program focuses on globally established veterinary medicinal products and product families. **Duties & Responsibilities** + Accountable for conducting successful Requests for Information/Requests for Proposal/Pitches for RA US outsourcing. + Strategic and technical regulatory advice to RFI/RFP/Pitch Processes - Provides expert input - both technical and strategic - to RFI/RFP/Pitch documents, ensuring alignment with business objectives and regulatory standards. + Vendor Evaluation and Selection - Analyzes and assesses vendor responses and documentation, including feedback and impressions from vendor presentations and pitches, to support informed decision-making. + Initiation and Support of Infrastructure Projects - Proactively initiates and/or contributes to the planning, development, and implementation of infrastructure-related projects, supporting operational efficiency and strategic objectives. + Negotiation Excellence - Collaborates closely with Boehringer Ingelheim's Sourcing department during vendor negotiations, contributing subject matter expertise and ensuring alignment with internal requirements and expectations while striving for competitive rates. + Program Ownership and Strategic Oversight - Accountable for the success of the RA US outsourcing program, executed in collaboration with External Regulatory Affairs Services (ERAS). The program supports international Boehringer Ingelheim products within the existing portfolio, specifically those with multiple marketing authorizations and without regulatory data protection. + Portfolio Management - Oversees a diverse outsourcing portfolio comprising more than 70 products (different modalities) from various heritage lines, ensuring consistent regulatory support and operational excellence across all engagements. + Outsourcing Program Implementation - Leads the setup and operationalization of the outsourcing program, ensuring alignment with strategic and regulatory requirements. + Governance of Maintenance and Expansion Activities - Oversees governance of ongoing maintenance activities and regulatory dossiers, particularly in the context of geographical expansion. + Monitoring and Action Based on ERAS Reporting - Receives, reviews, and evaluates reports from ERAS, taking ownership of translating insights into actionable steps to ensure continuous improvement and compliance. + Escalation Management - Acts as the primary point of contact for internal escalation issues within Boehringer Ingelheim, with responsibility for resolving first-level escalations related to ERAS. + Effective management of allocated budget - Responsible for the efficient use of the allocated budget for Regulatory Affairs (RA) US outsourcing services, ensuring optimal value delivery. + Invoice Verification - Reviews and validates incoming invoices for accuracy and compliance with contractual arrangements. + Budget Monitoring and Planning - Continuously monitors and plans budget utilization, including the development and enhancement of tools to support financial tracking and forecasting. + Financial Reporting - Provides regular budget reports to relevant stakeholders, including Finance and Controlling, ensuring transparency and alignment with organizational financial objectives. + Accountability for Managing external partners within outsourcing program. **Requirements** + Advanced degree (PharmD, DVM, PhD, or MSc) in Life Sciences, Pharmacy, Veterinary Medicine, or a related field required. + Additional qualifications in Regulatory Affairs (e.g., RAC certification) are considered an asset. + Capabilities & Professional Expertise. + Demonstrates a high level of professional capability and strategic influence in international regulatory affairs, with a minimum of five years' experience managing regulatory procedures across the United States, European markets (CP, DCP, MRP), and non-EU regions. + Proven expertise in dossier compilation and the use of regulatory databases is essential to ensure compliance, efficiency, and data integrity across global submissions. Project Leadership & Strategic Delivery + Fluency in English and the ability to lead complex, cross-functional regulatory projects are critical. + Strong leadership in managing change, delegating effectively, and driving results across diverse regulatory landscapes and organizational boundaries. Core Competencies - The incumbent must bring advanced capabilities in: + Strategic Thinking: Translating regulatory complexity into actionable strategies that support global product maintenance and expansion. + Decision-Making & Persistence: Navigating ambiguity and regulatory challenges with resilience and sound judgment. + Communication & Negotiation: Influencing internal and external stakeholders across disciplines and cultures. + Organizational & Analytical Skills: Managing multiple priorities with precision and clarity. + Cross-Disciplinary & Cross-Cultural Collaboration: Building trust and alignment across global teams and vendor networks. Impact & Influence + Significantly contributes to Boehringer Ingelheim's regulatory success, operational excellence, and long-term innovation strategy. + Through expert leadership and strategic execution, ensures that regulatory outsourcing delivers measurable value, compliance, and stakeholder satisfaction. **Eligibility Requirements** : + Must be legally authorized to work in the United States without restriction. + Must be willing to take a drug test and post-offer physical (if required). + Must be 18 years of age or older. **Desired Skills, Experience and Abilities** **Additional Duties & Responsibilities** : + External Partner Management - Oversees and manages relationships with external service providers within the outsourcing program, ensuring alignment with strategic objectives and operational standards. + Primary Contact for Strategic and Escalation Matters - Serves as the first point of contact for external partners regarding strategic guidance and the resolution of escalation issues. + Contractual Compliance and Advice - Acts as the RA liaison for all matters related to the Frame Service Agreement, work orders, and purchase orders issued by contractors to Boehringer Ingelheim, ensuring compliance and smooth execution of contractual obligations. Steering Committee Meetings with Senior Management: + Organizes, leads, and moderates Steering Committee Meetings involving Senior Management from Boehringer Ingelheim and the external partner. + Ensures structured dialogue, strategic alignment, anticipation of future outsourcing needs and effective decision-making across both organizations. Accountability for Management of internal Boehringer Ingelheim stakeholders: + Actively engages with internal stakeholders by facilitating structured feedback exchange regarding the outsourcing program. + Ensures that external vendors operate in alignment with Boehringer Ingelheim's current processes and receive all required training. + Stakeholder satisfaction is monitored through periodic surveys, with actionable insights derived from the feedback to drive continuous improvement. **GI_US925** All qualified applicants will receive consideration for employment without regard to a person's actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.
    $99k-133k yearly est. 53d ago
  • Director, US Regulatory Affairs Pharmaceuticals

    Boehringer Ingelheim 4.6company rating

    Boehringer Ingelheim job in Athens, GA

    As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees. The Director, US Regulatory Affairs Pharmaceuticals leads the US Regulatory Affairs (RA) Pre and Post approval organization responsible for the Animal health portfolio of Pharmaceutical, nutraceutical, pesticide & New Innovative products; in close collaboration with Global RA, Global Innovation (GI), Global Supply (GS), Global Quality and Commercial Operations. This role is responsible for licensing and Safety & Efficacy support in the USA and International markets for all new product types and entities licensed via FDA-CVM & EPA and as well as Life Cycle Management of existing products in accordance with company priorities and governance. The Director, US Regulatory Affairs Pharmaceuticals is a key interface with US Regulatory Authorities such as the FDA & EPA and drives regulatory framework and BI position on key regulatory topics. The incumbent represents BI externally on a multinational basis. **Duties & Responsibilities** + Leads and is accountable for external representation: Key communication interface and influencer with Regulatory Authorities. + Responsible for proactively seeking contact with Authorities directly in the USA or through local RA as appropriate and positioning BI as a trusted and innovative partner (key account management). + Ensures a balanced relationship with the authorities. + Is a highly effective communicator with external authorities, agencies and internal stakeholders and senior leadership. + Provides clarity and interpret relevant legislation and translate into actionable areas to increase the predictability and probability of success for our projects and activities. + Works globally and closely in cooperation and collaboration with other RA leadership positions in the best interests of the global team ensuring agility, accountability and intrapreneurship across the function. + Leads regulatory support for Authority site inspections and provides leadership and advice to Clinical, GS and Quality. + Works globally and closely in cooperation and collaboration with other RA leadership positions in best interests of the global team to maintain agility, accountability and intrapreneurship across the function. + Leads leaders and technical experts and mentors regulatory teams and colleagues globally, providing innovative solutions to challenges of the organization and our portfolio. + Responsible for hiring, retaining and developing Regulatory team members and identifying talent for future success. + Seeks ways to measure and increase team engagement and productivity. + Ensures functional excellence of members and promotes an entrepreneurial and proactive spirit. + Demonstrates and promotes Our Behaviors with key stakeholders. + Responsible for managing cost center and budget for function and associated activities + Ensures integrity of our regulatory compliance with the respective authorities. + Provides service to all our operations in the respective scope of their responsibilities: Global Innovation, Global Supply, Strategic business units, Commercial operations including local RA teams in international locations. Is an internal service provider who is responsible (and accountable) for leading a team which: + Proactively and in an entrepreneurial manner provides guidance to GI project teams for optimal registration strategies in the USA, balancing compliance and risk factors with speed to market. + Prepares, submits and achieves marketing authorizations in a timely manner, achieving a competitive label. + Professionally and proactively addresses needs of internal stakeholders with urgency + Is responsible for increasing productivity that maximizes product lifecycle opportunities in line with business strategy. + Is responsible for maintaining up to date technical regulatory data and information for use in dossier preparation for BI submissions to Authorities. + Develops and implements strategies for quick resolutions of regulatory issues arising during the post approval and re-registration cycle. + Responsible for identifying regulatory trends and driving strategies to manage and address in the interests of BI. **Requirements** + Bachelor's degree required in Life Sciences such as Biology, Toxicology, Pharmacy or equivalent with fifteen (15) years of experience; Advanced degree e.g. PhD, Veterinary medicine or Medicine strongly preferred. + Fluent in English. + Expertise in Regulatory affairs is required with extensive authority interactions and a strong track record of successful influencing. + Proven leader with demonstrated ability to build and lead high performing teams. + Strong team player. + Demonstrated ability to successfully collaborate and lead people in a complex global organization. + Excellent communicator and negotiator with ability to form successful working relationships at all levels across disciplines and geographies. + Exhibits Our Behaviors. + Enthusiastic mentor, coach and developer of people. + Self-motivated decision maker, well organized, works to deadlines and with a high degree of initiative and persistence. + Experience building an organization and leading change management. + Willingness to travel up to 20%. **Eligibility Requirements** : + Must be legally authorized to work in the United States without restriction. + Must be willing to take a drug test and post-offer physical (if required). + Must be 18 years of age or older. GI_US925 All qualified applicants will receive consideration for employment without regard to a person's actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.
    $104k-130k yearly est. 60d+ ago
  • Attending Veterinarian

    Boehringer Ingelheim 4.6company rating

    Boehringer Ingelheim job in Colbert, GA

    As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees. The Attending Veterinarian plays a critical role in ensuring the health, welfare, and ethical treatment of animals within the research facility, while also supporting the advancement of scientific discovery and innovation. This position is responsible for overseeing the veterinary care program, which includes medical treatment, surgical procedures, and husbandry practices for a variety of species. By maintaining compliance with regulatory standards (IACUC, USDA, AWA, AWAR, AAALAC/Guide) and implementing robust health programs, the Attending Veterinarian ensures the facility operates at the highest standards of animal care and welfare. Beyond veterinary responsibilities, the Attending Veterinarian serves as a key collaborator with study teams, offering expertise in experimental design, protocol development, and study execution. This role demands a unique combination of technical veterinary skills, regulatory knowledge, and leadership capabilities to support the discovery, characterization, and development of novel vaccines and pharmaceutical products. By fostering a culture of excellence and innovation, the Attending Veterinarian contributes to the organization's mission of improving animal health and advancing scientific progress. **Duties & Responsibilities** + Oversight and Clinical Veterinary Support - Provides state of the art veterinary care, including outstanding technical capabilities (clinical measurements, surgical skills, etc.) in lab animals, companion animals, poultry, equine, etc. + Develops and implements preventive medicine programs to ensure the health and welfare of all animals. + Ensures full compliance with all veterinary regulatory requirements. + Oversees and enforces animal welfare standards across the facility, ensuring adherence to institutional, federal, and accreditation guidelines (e.g., USDA, AAALAC, IACUC). + Will be on call to see veterinary cases (emergencies or study sensitive events) that occur on weekends and holidays in addition to normal business days. + May be responsible for executing various aspects of study activities, including but not limited to study-related observations, sample collection (e.g., blood, swabs), and data recording. + Reviews raw data for accuracy and completeness, and prepare thorough, accurate reports as needed. + Provides regular updates on the progress of medical cases. + Evaluates study data, draw scientifically sound conclusions, and make recommendations for subsequent studies to support the continued evaluation of the lead candidate. + Applies knowledge of pertinent regulations (GLP, GCP, USDA memoranda). + Provides medically sound recommendations for sourcing approaches to ensure availability of unique and specially required experimental animals. + Trains and verifies the competency of researchers and technicians in veterinary clinical procedures and research activities. + May also be responsible for developing and managing training programs at both site-specific and cross-site levels. + Serves as a technical advisor to investigators and staff across R&D, providing guidance on clinical testing methods as well as the design, implementation, and completion of studies to evaluate new product leads. + Offers expert advice on site-specific and departmental programs, including biosecurity, sanitation, medical equipment and supply sourcing, preventive health programs, and more. + May also serve on cross-site or company-wide committees and workgroups, such as the IACUC, Global Animal Welfare Forum, and others. + Collaborates with Global Supply to ensure compliance with Quality Control procedures. + Demonstrates understanding of applicable regulations, including 9CFR and GDP. **Requirements** + DVM or VMD degree from an AVMA-accredited veterinary school, with eligibility to obtain licensure to practice veterinary medicine in the United States required. + Eligible to be licensed and accredited, including maintaining an active DEA registration. + Attendance / Schedule - Attendance requirements are governed by BI AH general attendance policies. Must be available to work weekends. + Visual Demands - Must be able to read and see clearly. Prescription eyewear is permitted. Physical Demands / Surroundings: + This position requires the ability to work in extreme environments (e.g., hot, cold, noisy, humid) with a strong emphasis on biosecurity, attention to detail, and timeliness. + The individual must demonstrate persistence and energy in a dynamic, fast paced, and demanding work setting. + Must be willing to work directly with animals during both ante-mortem and post-mortem procedures. Temperament / Mental Requirements + Must maintain an even temperament when working with animals. The position requires a willingness to learn quickly. + The individual must be results-oriented, cooperative, and a systematic thinker. + Must be capable of working in a multidisciplinary, matrixed environment and value the importance of teamwork. + Sound judgment and analytical thinking are essential. + The individual must demonstrate the ability to manage processes and projects, and function effectively in team or committee roles. Other Proficiencies: + Must possess effective verbal and written communication skills in English, sufficient for accurate internal information exchange. + Requires the ability to interface and build working relationships with team members at all levels of the site organization. + Must be proficient in basic computing skills, including email communication and word processing. These physical and mental requirements represent a sample of those considered essential to this position. While accurate, this list is not exhaustive and may be revised or updated as needed. **Eligibility Requirements** : + Must be legally authorized to work in the United States without restriction. + Must be willing to take a drug test and post-offer physical (if required). + Must be 18 years of age or older. All qualified applicants will receive consideration for employment without regard to a person's actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.
    $139k-189k yearly est. 60d+ ago
  • Principal Specialist, Validation

    Boehringer Ingelheim 4.6company rating

    Boehringer Ingelheim job in Athens, GA

    As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees. The Principal Specialist, Validation manages all phases of higher level, more complex validation project activities at the BIAH location from concept through process validation ensuring GxP regulatory compliance continues as outlines in BIAH's Validation Master Plan (MVP) and Corporate Policies and Procedures. This position is critical to the compliance effort and is responsible for assuring compliance of validated systems, process, equipment to current cGMP, FDA, EU, USDA, BIAH and BI corporate requirements. This includes, but is not limited to scheduling resources, conducting testing, and verifying facilities, utilities, equipment, systems and processes meet specifications and requirements and are suitable for their intended purposes. The Principal Specialist, Validation will lead project management efforts for validation activities associated with major site capital projects as well as oversee small department projects and provide technical support to team members. This includes, but is not limited to, contractor oversight, document review, deviation management and CAPA assessment, as applicable. Provide department review/approval to routine validation documents. This position serves as a subject matter expert for internal and external department/site and global projects. **Duties & Responsibilities** + Responsible for managing higher level, more complex GMP validation project activities at the BIAH US locations from concept through process validation as outlined by BIAH's Validation Master Plan (VMP) and Corporate Policies and Procedures. + Maintains site validation database and document systems, supports feasibility studies, equipment review, selection, acquisition and upgrade. + Develops and maintains higher level departmental and site standard operating procedures (SOP) and training on quality principles. + Promotes staff development and growth, performs training to staff and other departments. + Leads and actively supports strategic direction of validation philosophies, improve overall validation system and process flow incorporating into BIAH VMP. + Provides oversight and document review for smaller validation projects and routine Validation Maintenance deliverables. + Develops and Maintains local standard operating procedures to follow all FDA/EU/USDA regulations, as well as Corporate procedures. + Serves on assigned internal and external project teams (change controls, deviations, technology transfer) as a technical/compliance resource to solve quality related issues and/or support continuous improvement. + Trains personnel in quality and validation principals + Supports Engineering and departments in the selection, review, acquisition, and upgrade of systems and production equipment. + Provides technical support in developing user and functional requirements specifications, URS, RA FRS and DQ for systems and equipment. + Participates with internal, regulatory or Corporate audits to ensure compliance with domestic and international regulations, quality requirements and guidance documents. + Develops and assists with audit responses and completion of assigned CAPAs by target due dates. + Responsible for ensuring Validation areas are "inspection ready" at all times. + Supports Change Control, Deviation and CAPA activities + Performs all company business in accordance with all regulations (e.g., EEO, FDA, etc.) and Company policy and procedures. + Demonstrated high ethical and professional standards with all business contacts to maintain BIAH's reputation in the community. + Immediately reports noted/observed violations to management. **Requirements** + Bachelor Degree in a relevant scientific, bioengineering or relevant discipline + Six (6) years GMP validation or similar experience in a GMP manufacturing or similar production environment + Minimum of ten (10) years GMP validation experience in a GMP or regulated manufacturing or similar environment in lieu of a degrees. + Experience must be inclusive of at least three (3) years leading projects. + Ability to plan, schedule, organize, prioritize and coordinate project activities. + Ability to function in a leadership role and within cross function teams. + Ability to analyze validation and production data to assess compliance with GMP requirements and/or troubleshoot compliance problems + Excellent written and verbal communication skills + Excellence in comprehension/application of FDA/EU/USDA regulatory requirements for production and distribution of regulated biological articles + Strong theoretical and practical knowledge of regulated processes and one technical discipline, such as biology to apply knowledge or experience to assigned tasks. + Ability to make decisions regarding the acceptability of product based on documentation provided. + Demonstrated ability to work with diverse groups of people and conflict management. + Skillful in using office application software (MS-Word, MS-Excel, MS-Outlook, PowerPoint). **Eligibility Requirements** : + Must be legally authorized to work in the United States without restriction. + Must be willing to take a drug test and post-offer physical (if required). + Must be 18 years of age or older. **Desired Skills, Experience and Abilities** All qualified applicants will receive consideration for employment without regard to a person's actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.
    $102k-128k yearly est. 31d ago
  • Technician III, Animal Caretaker

    Boehringer Ingelheim 4.6company rating

    Boehringer Ingelheim job in Gainesville, GA

    The Person employed in this job will assist with Animal Care and performance of testing at the Candler Poultry Center and be support and secondary planner/scheduler. As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees. **Duties & Responsibilities** + Caring for birds (feed, water, air). + Vaccinate, bleed, and assist in necropsies of birds with veterinarians. Includes entry of test information in LIMS system or other data systems. + Cleaning of isolation units or test cages. + Reporting of daily observations of birds. + Reporting of any equipment failure. All areas are maintained and work area clean and orderly + Proper use of all safety procedures and Record keeping skills + Be support and secondary planner/scheduler including management, implementation, and documentation of Avian QC safety and potency testing to meet serial release dates. Ensure compliance with USDA regulations and other regulatory agencies as required. + Some weekend work required. + Performs other duties as assigned. **May not own or have contact with other birds or poultry.** **Requirements** + High School Diploma or equivalent required. + Associate's Degree from an accredited institution in animal science related field preferred. + Five-plus (5+) years of experience working with animals preferred. + Three-plus (3+) years of experience working with animals preferred. + Experience working with poultry preferred. + Must be conscientious, detail-oriented, self-motivated, and able to work alone. + Must realize the importance of non-contamination process and be prepared to adhere strictly to the procedures. + Ability to maintain good working relationships with others. + Good communication skills. + Excellent record keeping skills. + Must be able to lift 70 lbs. + Must have and maintain a clean driving record. + Computer skills. + Must be able to work from a ladder. + Must be able to stand for long periods of time. + Must be able to squat, bend, and stoop, as well as twisting and turning. + Manual dexterity and visual acuity are important. + Must be able to work a rotating on call schedule. + Must be able to work a rotating weekend schedule. + Attendance is a must. + Must not own poultry or pet birds and not reside in the same household with someone who does. **Desired Skills, Experience and Abilities** All qualified applicants will receive consideration for employment without regard to a person's actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.
    $56k-72k yearly est. 60d+ ago
  • Veterinarian, Key Account, Poultry

    Boehringer Ingelheim 4.6company rating

    Boehringer Ingelheim job in Duluth, GA

    The Veterinarian, Key Account for Poultry will participate in a team-selling environment and provide technical support and expertise to the sales/marketing efforts of BIAH poultry products. The veterinarian in this position will assume the technical support role of assigned key accounts and through extensive collaboration with the Key Account Manager(KAM). This role will help execute a strategy that provides technical support and solutions to customers that will ultimately drive mutual opportunities, revenue and growth. As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees. **Duties & Responsibilities** + Provide technical support to key poultry accounts. Technical support may involve educating customers on BIAH products and data, consultation on health programs, animal husbandry, management, diagnostic investigations, etc. Although this role will have a broiler focus, it may also support the commercial table egg layer and turkeys as needed. + Develop a thorough understanding of the business model, goals and needs of assigned accounts. Assist KAM in development of account plan and strategy for assigned accounts. Develop and foster relationships with key decision makers and other personnel in the accounts. + Assist KAM with identifying and completing training and educational initiatives for key account employees. Serve as a technical expert in disease outbreaks and other health related issues by working with account management, veterinarians to develop a diagnostic and treatment program, as well as, a program to prevent future outbreaks. + Work with customer, KAM, technical marketing managers, etc. to identify potential research opportunities that would benefit the customer and BIAH. Collaborate with technical marketing manager to develop protocols for review and conduct field studies as needed with approval by account and BIAH. + Provide technical expertise in poultry health in an area such as: + Custom made vaccines + Training and development + Commercially approved vaccines + Epidemiology/Stats + Diagnostics + Hatchery + Trials + Scientific presentations + Other areas to be determined + Support students and foster relations with faculty at veterinary schools,industry groups and professional organizations to assure they are up-to-date on poultry BIAH products and new data. + Performs all Company business in accordance with all regulations (e.g., USDA) and Company policy and procedures. When violations are noted/observed they are to be immediately reported to management. Demonstrates high ethical and professional standards with all business contacts in order to maintain BIVI's excellent reputation within the animal health community and internally.Communication and Administrative - process travel, MAP (marketing and promotions), university, samples, and professional development expenditures. May supervise others. **Requirements** + A veterinary degree (DVM or VMD) from an accredited institution is required. A degree from a AVMA accredited school is preferred. + Licensed to practice veterinary medicine in at least one state in the United States required. + Board certification in the American College of Poultry Veterinarians (ACPV) board or ability to become certified is preferred. + Minimum five (5) years of relevant poultry industry experience (production medicine, technical service, etc.) in broiler production is preferred. + Animal health biologics industry experience is a plus. + Field-based position, living in poultry-concentrated area, with preference to Southeastern United States. + Willingness to travel up to 50-65% of time (will include overnight travel). + Requires a thorough understanding of veterinary medicine, diseases, production and management, diagnostics and use of vaccines/pharmaceuticals in disease prevention/control programs. + Proficiency in Microsoft Office, Outlook, PowerPoint and database applications. + Proven successful public speaking and presentation skills are required. + Must work effectively with intermittent supervision. + Solid interpersonal skills and group communication skills are required. + Valid Driver's License and an acceptable driving record. + Authorization and ability to drive a Company leased vehicle or authorized rental vehicle. **Eligibility Requirements** : + Must be legally authorized to work in the United States without restriction. + Must be willing to take a drug test and post-offer physical (if required). + Must be 18 years of age or older. All qualified applicants will receive consideration for employment without regard to a person's actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.
    $107k-147k yearly est. 31d ago
  • SR AD, US RA Intelligence and External Engagement

    Boehringer Ingelheim 4.6company rating

    Boehringer Ingelheim job in Duluth, GA

    As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees. The Senior Associate Director of US Regulatory Affairs Animal Health Intelligence and External Engagement is responsible for advancing Boehringer Ingelheim's (BI) regulatory intelligence and engagement strategies for US Animal Health. This role leads key initiatives, builds relationships with federal and state health authorities (e.g., FDA-CVM, USDA-CVB), industry groups, and ensures BI's proactive involvement in shaping the regulatory landscape. Working closely with the Director and senior leaders, the position translates regulatory trends across healthy authorities, scientific disciplines, and geographies, into actionable strategies and aligns efforts with BI's business objectives. This position is a key interface with US and key market Regulatory Authorities and represents the company externally on a multinational basis with domestic and global trade associations. The Senior Associate Director of US Regulatory Affairs Animal Health Intelligence and External Engagement provides technical regulatory expertise to our operations in the respective scope of their responsibilities: Global Innovation, Global Supply, Global Strategic Marketing, US Commercial Operations, Global and US Regulatory teams. The incumbent serves as RA Project Leader for Global and US cross-functional teams responsible for new product registrations and life cycle management. **Duties & Responsibilities** Strategic Key Interface with Health Authorities, Trade Associations, and Stakeholders: + Acts as subject matter expert and key representative for BI in external communications with US health authorities, industry associations, and other stakeholders. + Develops and oversees execution of BI's external engagement strategy, ensuring effective communication of BI's regulatory positions and priorities. + Builds and maintains strong relationships with external stakeholders, positioning BI as a trusted partner in the animal health regulatory space. + Key communication interface and influencer with the animal health regulatory authorities, responsible for proactively seeking contact with regulatory authorities directly in the USA or through local and global RA as appropriate and positioning BI as a trusted and innovative partner (key account management). + Develops and provides strategic technical regulatory insights to cross-functional teams to inform product development and lifecycle management. Driving External Regulatory Engagement, Intelligence, and Policy Development: + Leads the development and execution of a regulatory intelligence strategy for the US Animal Health business by serving as technical expert that can bridge the scientific considerations with the regulatory landscape in alignment with business priorities. + Provides insights and recommendations to internal stakeholders on regulatory changes and opportunities that impact new product registrations and licensed products. + Leads the development of BI's technical regulatory policy positions and their integration into strategic planning processes by collaborating with internal and external subject matter experts and synthesizing a scientifically sound regulatory strategy for external engagement with federal and state health authorities. Support Leadership with Team Development, and RA Organizational Excellence: + Actively Leads the drafting and ensures review of SOPs and related documents, within an environment of continuous improvement. + Leads across BI by coaching, training and advising teams and upcoming experts to advance science, technology and regulatory strategy. + Identifies and attracts talent within and to the organization. + Proactively shares trends with others to foster collective success within the US Regulatory Intelligence and External Engagement team, and Global Innovation, Global Supply, and Commercial, fostering a culture of collaboration, innovation, and excellence. + Oversees and ensures development training materials for internal and external stakeholders. + Leads and/or participates in training initiatives related to technical or regulatory aspects of our products. + May be responsible for writing of technical pieces for use by other departments within Global Innovation, Global Supply, or Commercial Operations. + Mentors and develops team members, ensuring they have the skills and expertise needed to support BI's regulatory and business objectives. + Acts as a role model for support and collaboration within the organization, demonstrating BI's core values and commitment to regulatory excellence. + Drives alignment across functions and disciplines, locally and globally, to ensure the overall success of the company and US RAPV function. **Requirements** + Advanced degree in pharmacy, life sciences, or a closely related discipline is required (e.g., Master's, DVM, PhD). + Minimum of seven (7) years of experience in the pharmaceutical or animal health industry, with a focus on regulatory affairs. + Demonstrated experience in regulatory intelligence, policy analysis, and supporting advocacy efforts. + Practical experience with regulatory submissions, health authority communications, and lifecycle management activities. + Solid understanding of US regulatory requirements for pharmaceuticals and biologics. + Strong interpersonal and communication skills, with the ability to collaborate across internal teams and external stakeholders. + Ability to organize and prioritize workload, manage multiple tasks under pressure, and deliver within tight timelines. + Analytical thinker with a proactive mindset and the ability to adapt to evolving regulatory and business environments. + Willingness to share knowledge, contribute to team learning, and engage in scientific and regulatory discussions. + Proficiency in Microsoft Office applications and familiarity with regulatory databases and tools. + Effective project management and organizational skills. Leadership Experience: + Experience leading or mentoring team members and contributing to cross-functional initiatives. + Ability to influence internal stakeholders and support engagement with regulatory authorities and industry groups. Skills and Competencies: + Strategic mindset with the ability to align regulatory insights with business objectives. + Strong written and verbal communication skills, with the ability to convey complex information clearly. + Collaborative and adaptable, with a commitment to continuous learning and process improvement. + Skilled in managing competing priorities in a dynamic, cross-functional environment. **Eligibility Requirements** : + Must be legally authorized to work in the United States without restriction. + Must be willing to take a drug test and post-offer physical (if required). + Must be 18 years of age or older. GI_US925 **Desired Skills, Experience and Abilities** **Additional Duties & Responsibilities** : Strategic Regulatory Intelligence, Policy Development, and Risk Management: + Provides the technical regulatory expertise for development and execution of a comprehensive regulatory intelligence strategy for the US Animal Health business, ensuring timely identification and analysis of regulatory and scientific trends and emerging policies. + Provides strategic insights and recommendations to internal stakeholders on the impact of regulatory changes and opportunities for BI. + Develops BI's technical and operational regulatory policy positions, ensuring alignment with BI's business priorities and advocacy efforts. + Oversees the appropriate mapping of internal and external stakeholders, dissemination of regulatory intelligence across the organization, ensuring all stakeholders are informed and prepared to respond to regulatory changes. + Directs cross-functional strategic initiatives addressing emerging regulatory challenges, accelerating product approvals, and supporting life cycle management of products. + Proactively assesses and mitigates regulatory risks to safeguard BI's interests. + Leads development, maintenance, and expansion of a diverse, international network of internal and external experts (including key opinion leaders, academics, consultants, industry association leaders and regulatory authorities). + Leads negotiations with authorities and lead trade association working groups to develop policy, regulations and guidelines for the benefit of the industry. + Creates precedents with health authorities using sound scientific data, knowledge of industry, and understanding of regulatory landscape. + Positions BI as a trusted and innovative partner (key account management). Contribute to Cross-Functional Collaboration and Influence: + Provides expert consultation and advice across Boehringer-Ingelheim Animal Health to influence GI portfolio strategy, successfully advance novel modalities, complex projects and resolution of significant issues (such as, new technologies, new modalities, new product research and development, new external partnerships, global systems, policy and/or external influencing). + Remains at the cutting edge of scientific and regulatory knowledge in the assigned field of expertise and related fields (e.g. new technologies, new modalities, new product research and development, external partnerships, global systems, policy and/or external influencing) by creating and leveraging an extensive network of external (including authorities, trade associations and competitors) and internal subject matter experts and information sources. + Proactively communicates knowledge with relevant governance committees, leadership teams and other influential stakeholders within the organization. + Drives alignment and strategic collaboration across US and global functions including Legal, Corporate Affairs, Commercial, Pharmacovigilance, and Global Innovation. + Serves as a senior advisor and influencer, ensuring regulatory perspectives are embedded in business decisions and new product registration plans. + Acts as a senior influencer within BI, driving cross-functional alignment on regulatory intelligence, policy development, and external engagement strategies. + Develops strategic guidance to cross-functional teams on regulatory matters, ensuring alignment with BI's business priorities anticipating regulatory trends and collaborating with global and local teams to influence new regulations and guidelines with health authorities to create regulatory predictability. All qualified applicants will receive consideration for employment without regard to a person's actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.
    $92k-120k yearly est. 60d+ ago
  • Director, Scientific Expert CMC

    Boehringer Ingelheim 4.6company rating

    Boehringer Ingelheim job in Duluth, GA

    As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees. The Director, Scientific Expert CMC is responsible for providing new product and marketed product regulatory strategy in the Global Regulatory Affairs (RA) Chemistry, Manufacturing and Controls (CMC) function for pharmaceutical biotech and vaccine products in line with Company policies, business strategies and priorities in close collaboration with Quality, R&D and Operations/Manufacturing. The Director, Scientific Expert CMC provides subject matter expertise in functional areas related to, and driven by, Chemistry, manufacturing and or control strategies for chemical, biotech and vaccine products. The incumbent may serve as a Global Regulatory Project Lead within the project core team or serve as a functional expert on complex technical topics. This role requires demonstrated experience in animal health, particularly in the development and regulatory strategy of vaccines. Familiarity with veterinary biologics and regulatory pathways specific to animal health products is preferred **Duties & Responsibilities** + Spearheads the preparation, critical review, and timely submission of regulatory dossiers to global Health Authorities, ensuring alignment with evolving international standards and regulatory expectations. + Provides strategic technical knowledge across cross-functional teams, leveraging deep expertise in Chemistry, Manufacturing, and Controls (CMC) to guide the development and execution of robust regulatory and quality strategies. + Demonstrates a proven track record of regulatory success, underpinned by extensive experience and a high level of technical competency, ensuring that product development objectives are achieved efficiently, compliantly, and in alignment with corporate goals. + Defines, plans, and oversees the development of high-quality CMC regulatory submissions, with a focus on securing timely approvals from global Health Authorities. + Delivers expert, topic-specific regulatory guidance tailored to international requirements, ensuring alignment with global business strategies and collaborative objectives across strategic partnerships. + Proactively assesses and resolves complex CMC-related risks, recommending strategic actions and managing end-to-end processes to ensure regulatory compliance and operational efficiency. + Provides expert guidance, direction, and training to cross-functional teams based on a deep and current understanding of global regulatory requirements, submission timelines, and Health Authority expectations. + Interprets and applies regulatory standards to uphold excellence in R&D and Manufacturing, serving as a key resource for regulatory insight and compliance strategy. + Collaborates closely with R&D, Operations, Quality Assurance, and Legal teams to ensure consistent quality and regulatory alignment across internal manufacturing and external partnerships with Contract Manufacturing Organizations (CMOs). + Serves as a trusted subject matter expert (SME) in product development, actively contributing to cross-functional project teams and providing high-level regulatory consultation throughout the product lifecycle. + Delivers expert evaluations of potential licensing opportunities, offering comprehensive global CMC regulatory assessments to support strategic business development initiatives. + Provides authoritative guidance across the regulatory function, interfacing with internal departments and external manufacturing sites to ensure full compliance with regulatory standards governing BIAH products and processes. + Represents regulatory affairs as a key leader during manufacturing site inspections, offering critical insights and direction to Operations and Quality teams to ensure alignment with Health Authority expectations and inspection readiness. + Works with and develop professional relationships with regulatory agency contacts and regulatory industry groups; discuss and negotiate issues with regulatory agencies. + Acts as primary liaison to Health Authorities and BI Regulatory Teams for foreign registrations. + Establishes collaborative and productive relationships with key functional players within Boehringer Ingelheim and CMOs. + Understands/monitors regulatory trends and work with team to influence legislation/guidance and to inform organization of new guidelines, directives, and agency initiatives. + Acts as RA Subject Matter Expert regarding legislation and guidelines. + Proactively identifies and initiates departmental process improvements, drafts and reviews departmental processes and SOPs for activities relevant to this position and leads special projects as assigned. + Promotes a pro-active sense of ownership through agility, accountability and entrepreneurial action and mindset. + Aligns with global, regional, and local regulatory objectives and executes as per plan. **Requirements** + Advanced degree in Life Sciences and/or degree in Life Sciences with relevant experience required. + Proven leadership and project management skills. + More than fifteen (15) years of industry experience in a highly functioning position, conveying exposure to global Regulatory Authorities and Government Agencies. + More than ten (10) years of direct CMC experience in a pharmaceutical field. + Fluent in English. + Regulatory certification or degree preferred. + Highly adaptable and self-directed scientific professional with deep expertise in chemistry, biochemistry, and molecular biology, bringing a critical thinking mindset and the ability to manage complex, multidisciplinary workloads independently. + Demonstrates a robust command of pharmaceutical sciences, including small molecule and biologic drug development, analytical chemistry, formulation science, and regulatory CMC strategy. + Adept at integrating scientific knowledge with regulatory insight to drive innovation and ensure compliance across global markets. + Thrives under pressure, influencing cross-functional teams without direct authority, and fostering collaboration in dynamic, fast-paced environments. + Balances meticulous attention to detail with a strategic, systems-level perspective, ensuring both scientific rigor and alignment with broader organizational goals. + Exemplifies accountability by modeling integrity, making timely, data-informed decisions, and driving executional excellence through disciplined prioritization and cross-functional alignment. + Actively contributes to a culture of continuous learning and feedback, leveraging scientific acumen to mentor peers and elevate team performance. + With a strong intrapreneurial spirit, consistently transforms complex scientific concepts into actionable strategies and business outcomes. + Demonstrates agility in turning experimental data into insights, challenging assumptions, and applying learnings to accelerate development timelines. + Brings a professional, customer-focused approach to every engagement. + Willing to travel globally up to 20% to support strategic initiatives, regulatory interactions, and scientific collaborations. **Eligibility Requirements** : + Must be legally authorized to work in the United States without restriction. + Must be willing to take a drug test and post-offer physical (if required). + Must be 18 years of age or older. **GI_US925** All qualified applicants will receive consideration for employment without regard to a person's actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.
    $94k-129k yearly est. 60d+ ago
  • Executive Director, Animal Health Business Law

    Boehringer Ingelheim 4.6company rating

    Boehringer Ingelheim job in Duluth, GA

    As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees. The Executive Director, Animal Health Business Law is the senior legal advisor for BIAH USA Commercial Business, leading a high-performing legal and brand security team. This role will provide strategic legal counsel, drive operational excellence, and enable compliant innovation across a $2.4+B business. The incumbent provides a broad range of legal services, to clients at the CMC level or below as member of the Commercial Leadership Team. The level of counseling provided requires in depth knowledge of the business, management, and legal and regulatory environment; and the ability to communicate the legal risks associated with making specific strategic decisions. The impact of all legal advice provided at this level is extremely high, as President of BIAH USA and strategic decision makers incorporate expert counsel into their decision-making process. **Duties & Responsibilities** + Is the Primary Legal Advisor to President, BIAH USA and US AH Commercial Leadership Team. + Due to pervasive level of regulation, position requires knowledge and provision of advice on wide range of legal topics (e.g., FDA/EPA/USDA/FTC regulations and antitrust regulations). + Is a Member of BIAH USA Commercial Leadership Team and BIAH USA Legal Leadership Team. + Is a Strategic Business Partner to senior business leaders. + Drives cross-functional collaboration to deliver operational excellence in legal services. + Accountable for, in close coordination with Compliance Officer and VP, Litigation, compliance & risk management within US AH commercial teams and activities, as well commercial litigation & dispute resolution. + Manages a team of five (5), including three (3) attorneys, one (1) paralegal and one (1) brand security expert. + Mentors and trains attorneys, paralegals and other personnel within department. **Requirements** + Juris Doctorate required. + Six-plus (6+) year's leadership experience (i.e., leading employees, leading leaders, leading projects, leading business/functions). + Substantive legal knowledge and experience in areas of operations and regulatory law. + Knowledge of animal health or pharmaceutical industry; substantive understanding of compliance-related issues; general knowledge of litigation and risk management. + Understanding of regulatory and political changes on state, national, and international levels. + Strong business acumen, legal expertise, and negotiation skills. + Ability to evaluate risk and willingness to assume prudent risks. + High emotional intelligence and people leadership. + Willingness to travel up to >10% of time. **Eligibility Requirements** : + Must be legally authorized to work in the United States without restriction. + Must be willing to take a drug test and post-offer physical (if required). + Must be 18 years of age or older. All qualified applicants will receive consideration for employment without regard to a person's actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.
    $165k-251k yearly est. 48d ago
  • AD, Commercial Business Marketing - Equine

    Boehringer Ingelheim 4.6company rating

    Boehringer Ingelheim job in Duluth, GA

    As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.The Associate Director, Commercial Business Marketing is responsible for marketing design, activation, analytics, reporting, communication, and execution across the species segment(s) within the US Commercial organization. This role supports Marketing activities including, but not limited to, sales promotions, sales force communication and alignment, marketing activation, and customer experience delivery within applicable species segments. The incumbent develops and integrates new processes and establishes best practices in Commercial Marketing.The Associate Director, Commercial Business Marketing works cross-functionally to support internal stakeholders (i.e., Customer Experience, Head of Brand Marketing, Brand Managers) in coordinating species segment incentive planning, budgeting, and evaluating the impact of marketing activities (i.e. ROI, value creation). **Duties & Responsibilities** + Researches, analyzes and interprets relevant market data and conditions as means to develop and deploy innovative marketing solutions, promotions, strategic projects and pricing plans that strengthen and enhance revenue opportunities. + Influences Commercial Sales Reps through effective and timely communication and activation to meet and exceed strategic marketing planning and product positioning set forth by global and local Commercial leadership. + Establishes and delivers 'customer centric' marketing priorities and key initiatives, effectively uses resources, cross-functionally collaborates, maintains species segment focus, identifies and eliminates inefficient processes, duplicative efforts and roadblocks, identifies innovative way of working, and effectively partners with internal stakeholders across the network. + Cross-functionally collaborates and communicates within the species segment to effectively streamline the marketing promotion and incentive processes based on customer need and to enhance the Territory Manager and customer relationship. + Oversees the sales and promotional mix to optimize sales and promotion spends for the segment(s) of responsibility. + Meets individual and family brand objectives by developing 'outside the box' forms of promotions (i.e., digital, sponsorships, PR, etc.) that meet brand objectives and align with customer needs. + Executes cross- functionally within Local and Global Commercial and the various species segments to identify business opportunities impacting pricing and rebates, sales force communication and alignment, marketing activation, and delivery of the desired customer experience. + Leads and directs strategic initiatives and established project teams. + Allocates resources and oversees change management functions necessary to successfully complete assigned projects. + Partners cross-functionally and across species to develop and deliver new Marketing strategies and best practices in support of long-term company growth. + As needed, supports the training and development of less experienced commercial marketing personnel. **Requirements** + Bachelor's degree Marketing, Public Relations, Business or related discipline. + In addition to Bachelor's degree, incumbent must have a minimum of eight (8) years progressive experience designing and leading strategic marketing activities including sales promotions, pricing and rebates, sales force communication, marketing activation, customer experience delivery, and/or other relevant commercial marketing capabilities within a Commercial Function (Product/Brand Marketing, Commercial Experience, or a customer facing role). + Experience within a Pharmaceutical or Animal Health organization is strongly preferred. + Ability to travel 5-10%. + Exhibit strong written and verbal communication skills along with excellent presentation and facilitation skills. + Strong interpersonal skills and demonstrated ability to develop stakeholder relationships. + Demonstrated ability to collaborate and gain buy in from stakeholders to deliver results in a highly matrixed organization. + Demonstrated organization, planning & project management skills along with solid decision making & negotiation skills. + Proven ability to work on multiple high level cross functional projects & prioritize effectively. + Demonstrated strategic thinking, initiative, and creativity and proven track record for innovation. + Demonstrated problem solving and analytical skills. + Entrepreneurial drive with proven track record of exceeding financial and other quantitative goals as well as qualitative goals. + Demonstrated agility with a proven ability to develop and evolve strategic & tactical elements based on research data & industry trends. **Eligibility Requirements** : + Must be legally authorized to work in the United States without restriction. + Must be willing to take a drug test and post-offer physical (if required). + Must be 18 years of age or older. All qualified applicants will receive consideration for employment without regard to a person's actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.
    $112k-171k yearly est. 6d ago
  • Maintenance and Utilities Technician V

    Takeda Pharmaceuticals 4.7company rating

    Social Circle, GA job

    By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice (************************************** and Terms of Use (********************************************* . I further attest that all information I submit in my employment application is true to the best of my knowledge. **Job Description** **About the role:** As the Maintenance and Utilities Technician V, you will perform advanced maintenance, preventive maintenance, and repairs on a variety of critical plant equipment. You will ensure the smooth operation of manufacturing and facilities equipment, contributing to the efficiency and reliability of Takeda's operations. **How you will contribute:** + Perform preventative, corrective, and predictive maintenance on: + HVAC, chillers, boilers, air handlers, refrigeration systems, compressors, pumps, water systems + Diagnose, troubleshoot, and repair control systems, instrumentation, and mechanical systems + Maintain refrigerant logs per EPA/SCAQMD standards + Execute and close work orders (JDE system), including required documentation and Change Control + Escort contractors, support equipment startups, order/manage chemicals + Ensure compliance with NFPA, NEC, UMC, cGMP, and internal safety protocols + Respond to emergency/urgent utility issues and hazardous waste concerns + Participate in team meetings and instructor-led training + Demonstrate increasing technical proficiency over time **What you bring to Takeda:** + High School diploma or GED required + 8+ years of relevant industrial maintenance experience required + 2-year technical certificate (HVAC, Utilities, Building Trades) or military equivalent; Class 3 Industrial Wastewater Certification strongly desired. Automation/controls experience (DeltaV, Honeywell) highly preferred + Experience interpreting schematics, manuals, job plans. Experience with PID loops, Lockout/Tagout, ACAC protocols + Basic understanding of GMPs and regulated environments. Familiar with CMMS (JDE, Maximo), Microsoft Office, SCADA **Important Considerations:** At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. In this role, you may: + Carry up to 25 lbs., lift up to 50 lbs., and push/pull > 100 lbs. (with the assistance of material handling equipment). + Stand for extended periods of time over an entire shift. + Climb ladders and stairs while wearing special gowning. + Perform bending, twisting, reaching overhead, and/or squatting motions to perform certain tasks. + Work in controlled environments requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body. + Will work in a cold, wet environment. + Work multiple shifts, including holidays and shutdown. Must be able to work overtime as required. **More about us:** At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. \#GMSGQ #ZR1 #LI-MA1 **Takeda Compensation and Benefits Summary** We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. **For Location:** USA - GA - Social Circle - Hwy 278 **U.S. Hourly Wage Range:** $23.56 - $37.02 The estimated hourly wage range reflects an anticipated range for this position. The actual hourly wage offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual hourly wage offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. **EEO Statement** _Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law._ **Locations** USA - GA - Social Circle - Hwy 278 **Worker Type** Employee **Worker Sub-Type** Regular **Time Type** Full time **Job Exempt** No
    $23.6-37 hourly 60d+ ago
  • SR Expert, Manufacturing Science and Technology

    Boehringer Ingelheim 4.6company rating

    Boehringer Ingelheim job in Gainesville, GA

    As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees. The Senior Expert, Manufacturing Science and Technology will support BIAH products and processes with specialized technical analysis and recommendation throughout product / process life cycle. This role will explore and research new technologies to support future definition of innovative manufacturing platforms. The incumbent will support development and maintenance of technical body of knowledge for BIAH products and processes. The Senior Expert, Manufacturing Science and Technology will execute independent technical deliverables and appropriately sized technical projects as Project Leader, Subject Matter Expert or Project Contributor. **Duties & Responsibilities** Support BIAH products and processes with specialized technical analysis and recommendation throughout product / process life cycle: + Evaluates & approves minor/moderate change requests autonomously; assesses major change requests and provides recommendation for approval. + Analyzes process / product data and prepares reports in support of project. + Provides troubleshooting, root cause analysis and technical guidance for technical transfers, manufacturing deviations, validations, analytical tests, etc. + Provides technical input and support for questions received from Regulatory Authorities in various regulatory processes, e.g. geographical expansion of existing products, post approval changes on existing registrations. + Develops technical solutions for process optimization/ improvement of analytical test methods with possible impact on cost of goods. Explore, research, and assess technologies to support future definition of innovative manufacturing platforms: + Researches and analyzes existing BIAH technologies to support definition of Technology Standards. + Researches, assesses, and trends internal / external data sources to support Expert Position Papers. + Investigates and assesses new technologies for potential use in existing or new manufacturing processes. + Assists Scientists and other Subject Matter Experts in developing future-oriented Technology Platforms. Support development and maintenance of technical body of knowledge for BIAH products and processes: + Continually develops and maintains an appropriate individual level of theoretical and practical expertise to respond to the needs of BIAH. + Facilitates exchange of Technology expertise across global and local Manufacturing and Science Technology teams. + Captures and maintains ongoing product / process knowledge within global and local Manufacturing Science and Technology teams. Execute independent technical deliverables and appropriate size/complexity technical projects as Project Leader, Subject Matter Expert or Project Contributor: + Provides support to Operations Lead of CMC Development sub-team. + Technical assessment of user requirements, product or process changes. + Develops, structures, and leads cross-functional streams / projects aligned with project management methodology. + Proposes and manages scope, budget, schedule, and associated risks to deliver fully functional deliverables / projects meeting customer requirements. + Ensures compliance to regulatory requirements and BI / external standards (EHS, VICH, Corporate procedures, GxP etc.) + Establishes & maintains communication tools (e.g. project charter, monthly reports) to effectively communicate with all relevant stakeholders. + Ensures and measures customer satisfaction along the project lifecycle. **Requirements** + Ph.D. in scientific discipline (Pharmacy, Chemistry, Biochemistry, Biological sciences preferred) with a minimum of one (1) year direct industry experience. OR + Master's degree in scientific discipline (Pharmacy, Chemistry, Biochemistry, Biological sciences preferred) with a minimum of three (3) years direct industry experience. OR + Bachelor's degree in scientific discipline (Pharmacy, Chemistry, Biochemistry, Biological sciences preferred) with a minimum of five (5) years direct industry experience. + Additional qualification in Business (Supply Chain, Economics) preferred. + Professional Certification in Scientific field or Project Management preferred. + Expertise in novel technologies or sciences is an advantage. + Intense willingness to develop technical expertise at bench and production scale. + Ability to communicate in English required - additional language skills are an asset. + Willingness to travel domestically and internationally. + Strong interest for international/intercultural collaboration. + Training and experience in Agile Management preferred. + Ability to adapt communications and truly engage with diverse audiences. + Proven specialized/depth of knowledge in identified discipline. **Eligibility Requirements** : + Must be legally authorized to work in the United States without restriction. + Must be willing to take a drug test and post-offer physical (if required). + Must be 18 years of age or older. **Desired Skills, Experience and Abilities** All qualified applicants will receive consideration for employment without regard to a person's actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.
    $98k-121k yearly est. 3d ago
  • Field Sales Development Representative, Pets 2

    Boehringer Ingelheim 4.6company rating

    Boehringer Ingelheim job in Duluth, GA

    Boehringer Ingelheim Animal Health("BIAH" or the "Company")is a worldwide leader in Animal Health Pharmaceuticals. The Field Sales Development Representative (FSD) is a developmental role that simultaneously trains to be a future BIAH Sales Representative and supports the Field Sales team by providing outbound telephone coverage for a subset of field accounts. The FSD will also temporarily cover outside sale territories as part of the developmental program. BI AH's Field Sales Development Representative Program is the gateway for entry into the Pet Field Sales organization. The FSD is expected to complete a development program including BIAH technical product and sales training, on the job training including telephonic sales, field sales and in-clinic experiences. FSD's will work closely with field sales to grow share, gain new product penetration and uncover opportunities and threats while promoting the portfolio of BIAH products. The FSD team supports the Field Sales team by providing outbound telephone coverage for a subset of field accounts. Key performance indicators in this role include metrics for interactions with customers, orders taken, dollars sold and call quality. In addition to extensive internal sales training, the successful FSD will be asked to participate in several temporary field-based assignments. Assignment(s) would last between 2-3 months so the ability to temporarily relocate on short notice is a must. During these assignments, the FSD will be responsible for sales goals, market share and profitability results for the duration of the assignment. Anticipated time in the FSD position is between 18 to 24 months before being eligible to progress to a field based Sales Representative role. The ability to relocate is mandatory with preference for candidates willing to relocate anywhere in the US. The key measurement for success in this position is the accomplishment of individual and team sales objectives, training objectives and the attainment of BI AH's overall business performance. The FSD role is located in our BI AH Headquarters in Duluth, Georgia (in the Atlanta area); therefore, all candidates must currently reside in or be willing to relocate to the Atlanta area. We offer a nice relocation package for candidates open to relocating to the Atlanta area!Due to Covid-19, relocating to Atlanta may be delayed. Working remotely at the on-set of employment is likely and the company will continue to evaluate the work environment options as more is known. As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees. **Duties & Responsibilities** + Complete a development program including BIAH technical product and sales training, on the job training including telephonic sales, field sales and in-clinic experiences. + Work closely with field sales to grow share, gain new product penetration and uncover opportunities and threats while promoting the portfolio of BIAH products. + Contributes to the company sales targets by providing outbound telephone coverage for a subset of field accounts. + FSD will be asked to participate in several temporary field-based assignments. Assignment(s) would last between 2-3 months so the ability to temporarily relocate on short notice is a must. + Develops, utilizes and continuously improves product knowledge and effective selling skills in order to influence targeted animal health care professionals (AHCP) to support the use of BIAH promoted products. Executes brand strategies to ensure a consistent company sales and marketing message. + Utilizes CRM tool to create pre-call plans to meet animal health care professionals' (AHCP) needs. Follows defined CRM business rules. Sells towards AHCP business needs and opportunities. Fosters AHCP network development and communication. Have accurate and timely follow-up discussions with AHCP. Fosters ongoing trust with AHCP as relationship develops. Uses appropriate BIAH Sales Training techniques to facilitate the AHCP decision making process. + Performs all Company business in accordance with all regulations (e.g., EEO, FDA, etc.) and Company policy and procedures. When violations are noted/observed they are to be immediately reported to management. Demonstrates high ethical and professional standards with all business contacts in order to maintain BIAH's excellent reputation within the animal health community and internally. **Requirements** + Bachelor's degree from an accredited institution is required, with related experience in the veterinary industry or sales a plus. + Two-plus (2+) years of sales experience preferred + Must demonstrate an aptitude and desire to sell, gain market and service knowledge and demonstrate the ability to learn technical product knowledge. + In-depth knowledge of all BIAH products, be able to utilize sales processes, demonstrate persuasiveness, tenacity, and organizational skills. + Key competencies include: + Interpersonal skills + Drive + Resilience + Teamwork + Organization skills + Strong verbal and written communication skills. + Credible persuasive skills are necessary to initiate and close sales. + Strong telephone presentation abilities and computers skills are essentials Eligibility Requirements: + Must be legally authorized to work in the United States without restriction. + Must be willing to take a drug test and post-offer physical (if required). + Must be 18 years of age or older. All qualified applicants will receive consideration for employment without regard to a person's actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.
    $64k-89k yearly est. 4d ago
  • US_SR Associate, Quality Control Data

    Boehringer Ingelheim 4.6company rating

    Boehringer Ingelheim job in Gainesville, GA

    The SR Associate, Quality Control Data will manage the following functions in the Quality Control Department. This includes LIMS, Sample Life Cycle Management and Quality Control test documentation life cycle management in compliance with procedures and regulatory requirements. The incumbent will be responsible as an approved USDA sampler and providing Quality Assurance and Production support as needed.As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees. **Duties & Responsibilities** + Sample Life Cycle Management including responsible for daily sample submission receipt (including the maintenance of the logbook, LIMS, coolers, and freezers), preparation of retention samples and maintenance of retention samples and retention database. + Regulatory Compliance including responsible for preparation and shipment of USDA samples using APHIS Form 2020. + Documentation Life Cycle Management including responsible for managing Quality Control test documentation of active ingredient and final product (filing and generating associated test reports). + Data Integrity including responsible for Quality Control test record issuance and reconciliation. + Information Support including functioning as a Quality Control liaison with Planning, Quality Assurance and Production to provide necessary information regarding samples and test dates to allow proper management of formulation and packaging activities and management of safety stocks and back-order prevention. + Product Release including assisting in the preparation of accurate and timely submissions to USDA for product release using the APHIS Form 2008 and international documentation as needed to release product according to applicable procedures. + As assigned, assists in Conditional Releases, Early Expiration, Spanish/Brazil/ROW assignments and document creation/revision as needed according to applicable procedures. + Accountable to all related USDA, international, and GMP Biologics requirements at the Athens site for maintaining product registrations in >90 countries. + Ensures quality samples and data in Quality Control through: Management of samples, Distribution, and reconciliation of test documentation, Filing of test documentation, Generation of test reports as well as Planning and Production support for testing information. **Requirements** + Associates degree + 2 years of relevant industry experience required; Bachelor's degree in a scientific discipline, preferred. + Functional knowledge of computer systems such as laboratory information management systems (LIMS) is required. + Functional knowledge of product manufacturing activities is recommended. + Previous experience in a Manufacturing environment in Quality Assurance, Quality Control, or Production preferred. + Solid verbal and written communication skills, including document review and editing skills. + Detail oriented. + Strong time management skills. + Strong organizational skills with ability to multi-task and prioritize. + Experience in root cause analysis tools. + Ability to understand and comply with Quality Assurance and regulatory requirements (9CFR, Outlines of Production, Change Control, Deviation, CAPA, OOX, etc.). + Computer skills in Microsoft Office applications and the ability to learn new applications quickly and easily. **Desired Skills, Experience and Abilities** All qualified applicants will receive consideration for employment without regard to a person's actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.
    $91k-114k yearly est. 26d ago
  • Principal / Senior Principal Engineer, BMS

    Boehringer Ingelheim 4.6company rating

    Boehringer Ingelheim job in Athens, GA

    PRINCIPAL: This position has the primary responsibility of providing advanced design, programming and trouble shooting support for BMS related production and project activities. Primary work load supports plant engineering, construction and maintenance work and focuses on automated controls for building HVAC, plant utility systems and certain process utility systems. As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees. SENIOR PRINCIPAL: As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees. The Senior Principal Engineer, Building Management Systems (BMS) will manage a team of Building Management System (BMS) engineers and/or technical subject matter experts (SMEs) to serve as a BMS infrastructure and process-specific expert for one or more aspects building & infrastructure (B&I) systems that cover the warehouse production, packaging, site cooler systems, facilities and utilities. The incumbent manages the EMS, BMS systems, facility process system Integration, implementation, vendor management, production area B&I system support, maintenance support, including but not limited BMS/EMS systems and provide the onsite or off shift support calls. Expertise is applied by providing direct manufacturing facility support, troubleshooting of with the targeted B&I Automation system architecture as well as serving as technical and/or overall lead for capital projects involving the installation of new or modification of existing B&I system, equipment and/or utilities. **Duties & Responsibilities** PRINCIPAL RESPONSIBILITIES: + Maintain building management system (BMS) compliance with BIAH SOPs and current industry requirements. + Providing administrative services, such as end user access and training, to ensure conformance. + Primary resource for HVAC and utility system automation providing support to Production, Maintenance, and Engineering for system troubleshooting, root cause analysis of failures, and future corrective actions. Responsible for analysis of current programs including performance, diagnosis, and troubleshooting of problems, and designing solution to problematic programming. + Develop and implement system, facility, and production improvements in alignment with End User and strategic needs. + Provide support for BMS upgrades. + Oversee System Server support and maintenance. Assist in Development of preventive maintenance procedures and reliability based activities. + Work closely with management team in evaluating current systems and making decisions on future development of system. + Communicating directly with end users on issues, potential resolutions, or scheduled activities while track the utilization of BMS support functions. + Detailed design and programming (URS/FRS/DDS/Drawings/IOPQ) of BMS controls documents for new installations and renovations. + Coordinate project activities to minimize effect on production schedules and unexpected system outages. Provide programming, graphic design and system testing of controlled systems. + Responsible for planning, processing and performing all job tasks in an efficient manner with little direction from supervisor. Supervise other engineers and/or contractors on an ad hoc basis to support project goals and/or End User service levels. SENIOR PRINCIPAL RESPONSIBILITIES: Demonstrates technical leadership skills to support and lead a team of B&I automation engineers or tech to solve facility infrastructure challenges varying in both scope and complexity. Accountable to B&I budget management, vendor management and coordination for operations system deployment, and implementation schedule. Continues to foster the B&I engineer, tech for business and technical development. Capability to lead B&I engineers, tech, vendor and contractors for their role and responsibilities for key objects, including day to day operations or as members of a project team. Accountabilities for goal development and assessment of direct and indirect reports. Develops the B&I Automation strategy following global standards and align with the business needs of area of responsibility. Leads B&I automation system development, modification, and optimization efforts on a large scale and drive actions that require the buy-in and support from multiple other functions including but not limited to Operations, Quality, GI/GS, Project Engineering, and Maintenance (PME). Cross-functional leadership capability is essential. Develops and maintains overall knowledge of B&I Automation system platform, IT infrastructure and B&I System integration. Provides training on B&I system to end users as require for new or existing equipment/processes. Educates and mentors other facility tech, engineers, technicians, etc. to foster a continuous effort to bring others to the same level of expertise. **Requirements** PRINCIPAL REQUIREMENTS: + Master's Degree from an accredited institution in related engineering field with three (3) years' relevant working experience, or + Bachelor's Degree from an accredited institution in related engineering field with five (5) years relevant working experience, or + Associates Degree from an accredited institution and Professional Training in related engineering field with seven (7) years relevant experience or + Technical/Trade School Certification and Professional Training in related engineering field with ten (10) years relevant experience is required. + All relevant working experience would include maintenance/engineering roles such as controls, automation, project management, validation, electronics, refrigeration, and boiler operations. + Working experience with Building Management/Automation Systems is required. + Experience must include at least three (3) years in GMP regulated industry. + Expertise with Siemens Apogee, Siemens Insight, and Siemens Desigo systems is highly preferred. + Strong and effective inter-personal and communication skills and the ability to interact professionally with a diverse group. + Strong understanding of building and process automation systems and relation to bio-pharmaceutical industry validation / GMP requirements. + General knowledge of electronics, electrical wiring and communications equipment, HVAC equipment, and central utility equipment. + General knowledge of mechanical maintenance and construction of buildings, utility piping systems, production and facility machines. + Ability to read electrical schematics, P&IDs, and other technical drawings. + Familiarity with Good Engineering Practices, Commissioning, and Qualification. + Knowledge and understanding of biopharmaceutical regulations and good manufacturing practices is preferred. SENIOR PRINCIPAL REQUIREMENTS: B.S. degree in Engineering, Automation, Business or related field required. In addition to bachelor's degree, a minimum of seven (7) years relevant automation, BMS and/or control field experience in a regulated operations or similar environment. Experience must be inclusive of a minimum of two (2) years leading people or moderate to complex projects from end to end. Working experience with Building Management/Automation Systems is required. Strong and effective inter-personal and communication skills and the ability to interact professionally with a diverse group. Strong understanding of building and process automation systems and relation to bio-pharmaceutical industry validation / GMP requirements. General knowledge of electronics, electrical wiring and communications equipment, HVAC equipment, and central utility equipment. **Eligibility Requirements** Eligibility Requirements: Must be legally authorized to work in the United States without restriction. Must be willing to take a drug test and post-offer physical (if required). Must be 18 years of age or older. Desired Skills, Experience and Abilities All qualified applicants will receive consideration for employment without regard to a person's actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.
    $113k-141k yearly est. 23d ago
  • Plasma Center Technician - Entry-Level Phlebotomy Nights/Weekends

    Takeda 4.7company rating

    Snellville, GA job

    By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Please take this virtual tour to get a sneak peek of one of our Plasma Donation Centers. About the role: Every day, the donors you meet will motivate you. The high-quality plasma you collect will become life-changing medicines. Here, a commitment to customer service and quality is expected. You will report to the Plasma Center Manager and will perform as a plasma donor screener and perform phlebotomy to support plasma center operations. How you will contribute: · You will answer phones, and greet and focus on our donors, while ensuring the safety of donors and our team. · You will screen new and repeat donors and take and record donor vital signs and finger stick results. · You will use our Donor Information System, prepare donor charts, maintain accurate records, and coordinate donor compensation. · You will help identify operational opportunities for continuous improvement and initiate changes to center processes using company approved procedures. · You will be there for our donors, which includes working a variety of shifts, Saturdays and Sundays, and holidays. What you bring to Takeda: · High school diploma or equivalent · Ability to walk and/or stand for the entire work shift · Will work evenings, weekends, and holidays · Ability to lean, bend, stoop, crouch, and reach above shoulders and below knees · Ability to lift to 5 lbs., and occasional lifting of materials up to 32 lbs. and rarely 50 lbs. · Fine motor coordination, depth perception, and ability to hear equipment from a distance · Because of potential exposure to bloodborne pathogens (risk level 1), 90% of work tasks require prolonged glove wear · 1 or more years minimum experience working in a customer or patient facing role is helpful What Takeda can offer you: Every day at Takeda, we feel good knowing that what we do helps improve the lives of patients with rare diseases. At BioLife, while you focus on our donors, we will support you. We offer a purpose you can believe in, a team you can count on, opportunities for career growth, and a comprehensive benefits program to include retirement benefits, medical/dental, family leave, disability insurance and more, all in a fast-paced, friendly environment. More about us: At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to provide Better Health and a Brighter Future to people around the world. BioLife Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: USA - GA - Snellville U.S. Starting Hourly Wage: $16.00 The starting hourly wage reflects the actual starting rate for this position. The actual hourly wage offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. LocationsUSA - GA - SnellvilleWorker TypeEmployeeWorker Sub-TypeRegularTime TypePart time Job Exempt No
    $16 hourly Auto-Apply 27d ago

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