Quality Control Associate II - Temporary

Spectrum Pharmaceuticals, Inc.
Irvine, CA
The Quality Control Associate should be detailed oriented and will have responsibility for performing a variety of tasks related to Quality Control (QC) activities and related compliance programs supporting GxP activities. This position requires experience working in GxP regulated environments and practical knowledge in FDA and international regulatory requirements as applicable to development and investigational phase products.
Responsibilities:

* Assists in reviewing, processing, and maintaining company's QC activities through:

o Organization and maintenance of QC documents.

o Assisting in reviewing and processing Standard Operating Procedures (SOP), Forms, Reports, and equivalent GMP documents.

* Assists with continually evaluating laboratory procedures while independently identifying areas for improvement and assisting in the implementation of new practices.
* Performs regular follow-ups and tracks QC deviation and Out of Specification (OOS) investigation reports to closure.
* Performs regular follow-ups and tracks Open CAPAs to closure.
* Performs regular follow-ups and tracks open change controls to closure.
* Assists with generating and providing QC department Quality metrics.
* Assists with the review of stability testing documents.
* Batch Record Review - All QC testing related sections.
* Performs other related duties as assigned.

General Responsibilities:

* Operates to the highest ethical and moral standards.
* Complies with company's policies and procedures.
* Adheres to quality standards set by regulations and company's policies, procedures and mission.
* Communicates effectively with supervisors, colleagues and subordinates.
* Ability to participate effectively as a team player in all aspects of company's business.
* Demonstrate administrative leadership with knowledge-based expertise in related areas that can be applied to meeting company's strategic goals.
* Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company's policies and practices.

Required Skills, Education and Experience:

* BA/BS in Health Sciences or related field preferred.
* A minimum of 3 years of Pharma/Bio-Pharma experience in the quality assurance field.
* Batch Release experience required.
* Document Control/Records Management experience required.
* Demonstrates a thorough knowledge of GxP regulations and guidelines.
* Excellent written and oral communication skills and interpersonal skills.
* Ability to effectively manage multiple projects.
* Must be proficient in Microsoft Office applications.

Availability:

* Monday thru Friday 8 am to 5 pm with availability to work evenings and weekends, as required

Position Location and/or Territory and Travel

* Position is located in Irvine, CA

Position Type

* Temporary to permanent hire position

Spectrum Pharmaceuticals is an equal opportunity employer, we evaluate qualified applicants without regard to race, color, religion, sex, national origin, disability, veteran status, and other protected characteristics.

Executive Director of Clinical Development I

Spectrum Pharmaceuticals, Inc.
Boston, MA
The Executive Director directs all activities required to conduct and monitor clinical trials and ensures that Good Clinical Practices (GCP) are followed. Additionally, he/she helps formulate effective strategic goals and objectives and assures implementation and operational integration of those goals and objectives as directed by senior management. Overall, the Executive Director implements successful clinical programs that are completed on quality and on time.
Responsibilities:

* Play a leadership role in the strategy and managing of projects related to Phase I through Phase IV clinical research trials across the drug development process.
* Oversee and coordinate the operational aspects of ongoing projects to ensure corporate goals of time, cost and quality performance expectation are met.
* Guide clinical operations in outlining standard operating procedures (SOP) for Clinical Development that facilitate the development of drug research protocols, compliance with clinical/medical standards and compliance with industry standards.
* Develop and review protocols and interact with key external opinion leaders regarding protocol development.
* Develop relationships and work closely with trial investigators.
* Conduct investigator meetings and site visits.
* Implement and supervise clinical trials, including requests for eligibility and potential waivers.
* Monitor clinical trial progress including, but not limited to, drug safety, assessments and tracking of AEs, SAE and protocol deviations. Prepare SAE narratives for submission to regulatory affairs, reconcile SAE database, MedDRA and WHO coding.
* Analyze data, prepare and conduct iDMC meetings.
* Provide clinical expertise for drug-related medical problems arising at clinical sites.
* Interact with data management to timely and accurate support to data entry.
* Demonstrate leadership and interpersonal skills.

Drug Development Responsibilities:

* Interact with senior management and product team(s) regarding drug development strategy and plans.
* Interact with investigators and opinion leaders regarding protocol development.
* Contribute to writing of protocols, IB and annual reports.
* Participate in the interpretation of clinical data.
* Contribute to Clinical Study Reports.
* Contribute to the writing of safety section and clinical sections of IND and NDA submissions.
* Help create budgets and progress reports and other administrative tasks as required.

Required Skills, Education and Experience:

* Medical Degree required, with fellowship in medical oncology highly desired. Must have experience in Oncology Pharmaceutical drug development and experience in immune-oncology highly desired.
* Minimum of one to three years' experience in the pharmaceutical or contract research industries, or two years in academic clinical research.
* Knowledge of safety reporting principles and database coding, including FDA safety reporting regulations.
* Experience in writing patient narratives.
* Able to work independently, prioritize tasks efficiently and meet expected time frames.
* Able to perform thorough reviews of various medical documents/records in a timely manner.
* Able to prepare and verbally present a typical clinical data slide presentation.
* Able to interact and collaborate professionally across functional departments, regulatory agencies and investigators.

Availability:

* Available to work in the evenings and weekends, if and when required.
* Available to travel as required for business needs (eg investigator and site meetings; Medical congress).

Position Location and/or Territory and Travel:

* Position is located in Boston, MA.
* Position will require occasional travel

Spectrum Pharmaceuticals is an equal opportunity employer, we evaluate qualified applicants without regard to race, color, religion, sex, national origin, disability, veteran status, and other protected characteristics.

Clinical Trials Manager

Spectrum Pharmaceuticals, Inc.
Irvine, CA
Provides leadership and manages clinical trial activities. This position coordinates and collaborates with others in cross-functional teams; and oversees the deliverables and accountability of consultants, temporary staff, and contract research organizations (if applicable). This position is accountable for successful planning, implementation, monitoring and closure of clinical studies in accordance with Good Clinical Practices, other relevant regulations, and Spectrum SOPs.
Responsibilities:

* Manage Study Team to achieve corporate and Project Team milestones on time and on budget.
* Provide oversight of study team conducts to ensure overall study monitoring compliance.
* Develops full suite of planning tools for each clinical trial, including Study Oversight Plan, Clinical Monitoring Plan, enrollment plan, communication plan, contingency plan, start up and closure plan.
* Updates study plans with forecasts, including but not limited to site start up, enrollment, and closure.
* Tracks and reports study metrics (site and patient status, CRF completion, query status) against plan.
* Develops site budget in collaboration with Clinical Business Operation Manager.
* Develops and implements study-specific monitoring and site training tools, and oversees training.
* Reviews and approves site visit reports.
* Provides oversight of TMF submission and maintenance.
* Reviews and approves invoices from investigators and service providers.
* Provides Finance with activity forecasts to allow for appropriate accrual.
* Develops and fosters positive working relationships with colleagues, development and service partners.
* Acts as primary contact for all study activities.

Required Skills, Education and Experience:

* Five-year of experience with clinical trials as a CRA or related discipline.
* Five-years of experience leading teams.
* Strong working knowledge of GCP/ICH regulations.
* Demonstrated superior communication and collaboration skills.
* Strong organizational, planning and follow-through skills.
* Demonstrated leadership skills in multi-disciplinary situations.
* Ability to effectively interact with all levels of management.
* Ability to work well under pressure and with tight schedules.
* Ability to resolve problems positively and professionally.
* Have an in-depth understanding of clinical research. Have a working knowledge of the relevant SOPs.
* MS Word, Excel, in-depth knowledge of other presentation programs a plus.
* Excellent language and grammar skills, ability to write clearly and concisely.
* Attention to detail and the ability to prioritize.
* Ability to exercise judgment within generally defined practices and policies for obtaining data.
* Self-direction and motivation.
* Oncology experience preferred.

Position Location and/or Territory and Travel:

* Position is located in Irvine, CA or Boston, MA preferably, or Remote if necessary
* Position may require approximately 25% domestic and international travel.

Spectrum Pharmaceuticals is an equal opportunity employer, we evaluate qualified applicants without regard to race, color, religion, sex, national origin, disability, veteran status, and other protected characteristics.

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Clinical Trials Manager

Spectrum Pharmaceuticals, Inc.
Boston, MA
Provides leadership and manages clinical trial activities. This position coordinates and collaborates with others in cross-functional teams; and oversees the deliverables and accountability of consultants, temporary staff, and contract research organizations (if applicable). This position is accountable for successful planning, implementation, monitoring and closure of clinical studies in accordance with Good Clinical Practices, other relevant regulations, and Spectrum SOPs.
Responsibilities:

* Manage Study Team to achieve corporate and Project Team milestones on time and on budget.
* Provide oversight of study team conducts to ensure overall study monitoring compliance.
* Develops full suite of planning tools for each clinical trial, including Study Oversight Plan, Clinical Monitoring Plan, enrollment plan, communication plan, contingency plan, start up and closure plan.
* Updates study plans with forecasts, including but not limited to site start up, enrollment, and closure.
* Tracks and reports study metrics (site and patient status, CRF completion, query status) against plan.
* Develops site budget in collaboration with Clinical Business Operation Manager.
* Develops and implements study-specific monitoring and site training tools, and oversees training.
* Reviews and approves site visit reports.
* Provides oversight of TMF submission and maintenance.
* Reviews and approves invoices from investigators and service providers.
* Provides Finance with activity forecasts to allow for appropriate accrual.
* Develops and fosters positive working relationships with colleagues, development and service partners.
* Acts as primary contact for all study activities.

Required Skills, Education and Experience:

* Five-year of experience with clinical trials as a CRA or related discipline.
* Five-years of experience leading teams.
* Strong working knowledge of GCP/ICH regulations.
* Demonstrated superior communication and collaboration skills.
* Strong organizational, planning and follow-through skills.
* Demonstrated leadership skills in multi-disciplinary situations.
* Ability to effectively interact with all levels of management.
* Ability to work well under pressure and with tight schedules.
* Ability to resolve problems positively and professionally.
* Have an in-depth understanding of clinical research. Have a working knowledge of the relevant SOPs.
* MS Word, Excel, in-depth knowledge of other presentation programs a plus.
* Excellent language and grammar skills, ability to write clearly and concisely.
* Attention to detail and the ability to prioritize.
* Ability to exercise judgment within generally defined practices and policies for obtaining data.
* Self-direction and motivation.
* Oncology experience preferred.

Position Location and/or Territory and Travel:

* Position is located in Irvine, CA or Boston, MA preferably, or Remote if necessary
* Position may require approximately 25% domestic and international travel.

Spectrum Pharmaceuticals is an equal opportunity employer, we evaluate qualified applicants without regard to race, color, religion, sex, national origin, disability, veteran status, and other protected characteristics.

Strategic Account Manager - Washington, D.C.

Spectrum Pharmaceuticals, Inc.
Washington, DC
The Strategic Account Manager (SAM) position will currently be responsible for product sales and pull through for Rolontis (upon FDA approval) within a designated geography. The role also will be responsible for the creation, coordination and execution of strategic business plans for key accounts within the region based on market dynamics, GPO connectivity, and business analytics.
Responsibilities:

Responsibilities will include; 1. contract implementation and management 2. regional reimbursement knowledge, 3. develop and maintain strategic relationships with key decision makers, 4. identification of emerging trends and alternatives to the business model. All Rolontis promotional practices will be ethical and adhere to Spectrum's Compliance policies, the regulatory requirements of the FDA, OIG guidance, PhRMA code and other government agency guidelines.

* Achieve or exceed sales objectives in assigned geography for Rolontis while ensuring strict compliance with legal and regulatory standards.
* Effectively communicate and drive Rolontis customer agreements/contracts to internal and external stakeholders.
* Maintains a productive and compliant working relationship with our GPO partners within the Community & Hospital Oncology space.
* Develop strategically targeted account- specific business plans that reflect an in-depth understanding of local market forces.
* Lead cross-functional teams within Spectrum to develop long-term relationships with key accounts and stakeholders within the marketplace.
* Create, build and maintain appropriate relationships with key decision makers, administrators, and other HCP's in the clinic/hospital space.
* Understand national and local reimbursement policies for the assigned region.
* Develop local provider payer advocates to support corporate and/or brand initiatives.
* Effectively manage time, resources and workload.
* Effective verbal and written communication skills and organizational abilities.
* Demonstrate strong analytical acumen to ensure the appropriate focus is placed in the right areas of the market.
* Demonstrate ability to adjust to changing strategies to support corporate and/or brand while maintaining the highest level of performance.

Skills, Education and Experience:

* Minimum of 5 years of sales, sales management and/or account management experience in the pharmaceutical or biotech industry, Minimum of 2 years of sales in oncology.
* Bachelors degree, preferably in Life Science, Biology.
* Proven track record for delivering consistent sales results while maintaining highest ethical standards.
* Experience with physician-administered injectables a must, with hematology/oncology experience preferred.
* Expert understanding of the business of Oncology.
* Ability to work effectively in a team oriented, cross-functional environment while maintaining an entrepreneurial spirit, on a consistent basis.
* Ability to develop and grow strong professional relationships.
* Knowledge and experience of legal and compliance framework related to the pharma/biotech industries.
* Strong compliant track record of GPO relationships and executing GPO contracts in both the community oncology & hospital segments.
* Creative thinking and seeking innovative solutions to complex clinical/business problems.
* Must consistently demonstrate a commitment to a culture of compliance, integrity and business ethics.

Availability:

* Must be available to work in the evenings and weekends, as required.

Position Location and/or Territory and Travel

* Position is located in assigned regions Richmond (Washington, D.C.)
* Position will require 50% - 70% travel

Spectrum Pharmaceuticals provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

Strategic Account Manager - Birmingham

Spectrum Pharmaceuticals, Inc.
Alabama
The Strategic Account Manager (SAM) position will currently be responsible for product sales and pull through for Rolontis (upon FDA approval) within a designated geography. The role also will be responsible for the creation, coordination and execution of strategic business plans for key accounts within the region based on market dynamics, GPO connectivity, and business analytics.
Responsibilities:

Responsibilities will include; 1. contract implementation and management 2. regional reimbursement knowledge, 3. develop and maintain strategic relationships with key decision makers, 4. identification of emerging trends and alternatives to the business model. All Rolontis promotional practices will be ethical and adhere to Spectrum's Compliance policies, the regulatory requirements of the FDA, OIG guidance, PhRMA code and other government agency guidelines.

* Achieve or exceed sales objectives in assigned geography for Rolontis while ensuring strict compliance with legal and regulatory standards.
* Effectively communicate and drive Rolontis customer agreements/contracts to internal and external stakeholders.
* Maintains a productive and compliant working relationship with our GPO partners within the Community & Hospital Oncology space.
* Develop strategically targeted account- specific business plans that reflect an in-depth understanding of local market forces.
* Lead cross-functional teams within Spectrum to develop long-term relationships with key accounts and stakeholders within the marketplace.
* Create, build and maintain appropriate relationships with key decision makers, administrators, and other HCP's in the clinic/hospital space.
* Understand national and local reimbursement policies for the assigned region.
* Develop local provider payer advocates to support corporate and/or brand initiatives.
* Effectively manage time, resources and workload.
* Effective verbal and written communication skills and organizational abilities.
* Demonstrate strong analytical acumen to ensure the appropriate focus is placed in the right areas of the market.
* Demonstrate ability to adjust to changing strategies to support corporate and/or brand while maintaining the highest level of performance.

Skills, Education and Experience:

* Minimum of 5 years of sales, sales management and/or account management experience in the pharmaceutical or biotech industry, Minimum of 2 years of sales in oncology.
* Bachelors degree, preferably in Life Science, Biology.
* Proven track record for delivering consistent sales results while maintaining highest ethical standards.
* Experience with physician-administered injectables a must, with hematology/oncology experience preferred.
* Expert understanding of the business of Oncology.
* Ability to work effectively in a team oriented, cross-functional environment while maintaining an entrepreneurial spirit, on a consistent basis.
* Ability to develop and grow strong professional relationships.
* Knowledge and experience of legal and compliance framework related to the pharma/biotech industries.
* Strong compliant track record of GPO relationships and executing GPO contracts in both the community oncology & hospital segments.
* Creative thinking and seeking innovative solutions to complex clinical/business problems.
* Must consistently demonstrate a commitment to a culture of compliance, integrity and business ethics.

Availability:

* Must be available to work in the evenings and weekends, as required.

Position Location and/or Territory and Travel

* Position is located in assigned regions (Birmingham)
* Position will require 50% - 70% travel

Spectrum Pharmaceuticals provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

Strategic Account Manager - Phoenix

Spectrum Pharmaceuticals, Inc.
Arizona
The Strategic Account Manager (SAM) position will currently be responsible for product sales and pull through for Rolontis (upon FDA approval) within a designated geography. The role also will be responsible for the creation, coordination and execution of strategic business plans for key accounts within the region based on market dynamics, GPO connectivity, and business analytics.
Responsibilities:

Responsibilities will include; 1. contract implementation and management 2. regional reimbursement knowledge, 3. develop and maintain strategic relationships with key decision makers, 4. identification of emerging trends and alternatives to the business model. All Rolontis promotional practices will be ethical and adhere to Spectrum's Compliance policies, the regulatory requirements of the FDA, OIG guidance, PhRMA code and other government agency guidelines.

* Achieve or exceed sales objectives in assigned geography for Rolontis while ensuring strict compliance with legal and regulatory standards.
* Effectively communicate and drive Rolontis customer agreements/contracts to internal and external stakeholders.
* Maintains a productive and compliant working relationship with our GPO partners within the Community & Hospital Oncology space.
* Develop strategically targeted account- specific business plans that reflect an in-depth understanding of local market forces.
* Lead cross-functional teams within Spectrum to develop long-term relationships with key accounts and stakeholders within the marketplace.
* Create, build and maintain appropriate relationships with key decision makers, administrators, and other HCP's in the clinic/hospital space.
* Understand national and local reimbursement policies for the assigned region.
* Develop local provider payer advocates to support corporate and/or brand initiatives.
* Effectively manage time, resources and workload.
* Effective verbal and written communication skills and organizational abilities.
* Demonstrate strong analytical acumen to ensure the appropriate focus is placed in the right areas of the market.
* Demonstrate ability to adjust to changing strategies to support corporate and/or brand while maintaining the highest level of performance.

Skills, Education and Experience:

* Minimum of 5 years of sales, sales management and/or account management experience in the pharmaceutical or biotech industry, Minimum of 2 years of sales in oncology.
* Bachelors degree, preferably in Life Science, Biology.
* Proven track record for delivering consistent sales results while maintaining highest ethical standards.
* Experience with physician-administered injectables a must, with hematology/oncology experience preferred.
* Expert understanding of the business of Oncology.
* Ability to work effectively in a team oriented, cross-functional environment while maintaining an entrepreneurial spirit, on a consistent basis.
* Ability to develop and grow strong professional relationships.
* Knowledge and experience of legal and compliance framework related to the pharma/biotech industries.
* Strong compliant track record of GPO relationships and executing GPO contracts in both the community oncology & hospital segments.
* Creative thinking and seeking innovative solutions to complex clinical/business problems.
* Must consistently demonstrate a commitment to a culture of compliance, integrity and business ethics.

Availability:

* Must be available to work in the evenings and weekends, as required.

Position Location and/or Territory and Travel

* Position is located in assigned regions (Phoenix)
* Position will require 50% - 70% travel

Spectrum Pharmaceuticals provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

Strategic Account Manager - San Francisco

Spectrum Pharmaceuticals, Inc.
California
The Strategic Account Manager (SAM) position will currently be responsible for product sales and pull through for Rolontis (upon FDA approval) within a designated geography. The role also will be responsible for the creation, coordination and execution of strategic business plans for key accounts within the region based on market dynamics, GPO connectivity, and business analytics.
Responsibilities:

Responsibilities will include; 1. contract implementation and management 2. regional reimbursement knowledge, 3. develop and maintain strategic relationships with key decision makers, 4. identification of emerging trends and alternatives to the business model. All Rolontis promotional practices will be ethical and adhere to Spectrum's Compliance policies, the regulatory requirements of the FDA, OIG guidance, PhRMA code and other government agency guidelines.

* Achieve or exceed sales objectives in assigned geography for Rolontis while ensuring strict compliance with legal and regulatory standards.
* Effectively communicate and drive Rolontis customer agreements/contracts to internal and external stakeholders.
* Maintains a productive and compliant working relationship with our GPO partners within the Community & Hospital Oncology space.
* Develop strategically targeted account- specific business plans that reflect an in-depth understanding of local market forces.
* Lead cross-functional teams within Spectrum to develop long-term relationships with key accounts and stakeholders within the marketplace.
* Create, build and maintain appropriate relationships with key decision makers, administrators, and other HCP's in the clinic/hospital space.
* Understand national and local reimbursement policies for the assigned region.
* Develop local provider payer advocates to support corporate and/or brand initiatives.
* Effectively manage time, resources and workload.
* Effective verbal and written communication skills and organizational abilities.
* Demonstrate strong analytical acumen to ensure the appropriate focus is placed in the right areas of the market.
* Demonstrate ability to adjust to changing strategies to support corporate and/or brand while maintaining the highest level of performance.

Skills, Education and Experience:

* Minimum of 5 years of sales, sales management and/or account management experience in the pharmaceutical or biotech industry, Minimum of 2 years of sales in oncology.
* Bachelors degree, preferably in Life Science, Biology.
* Proven track record for delivering consistent sales results while maintaining highest ethical standards.
* Experience with physician-administered injectables a must, with hematology/oncology experience preferred.
* Expert understanding of the business of Oncology.
* Ability to work effectively in a team oriented, cross-functional environment while maintaining an entrepreneurial spirit, on a consistent basis.
* Ability to develop and grow strong professional relationships.
* Knowledge and experience of legal and compliance framework related to the pharma/biotech industries.
* Strong compliant track record of GPO relationships and executing GPO contracts in both the community oncology & hospital segments.
* Creative thinking and seeking innovative solutions to complex clinical/business problems.
* Must consistently demonstrate a commitment to a culture of compliance, integrity and business ethics.

Availability:

* Must be available to work in the evenings and weekends, as required.

Position Location and/or Territory and Travel

* Position is located in assigned regions Richmond (San Francisco)
* Position will require 50% - 70% travel

Spectrum Pharmaceuticals provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

Senior Director of Drug Product Development

Spectrum Pharmaceuticals, Inc.
Irvine, CA
We are seeking a highly motivated professional to perform strategic planning and execution of drug product development and manufacture for its clinical development programs (phase 1, 2, 3), and planned commercial launch. The individual will provide proven leadership on all aspects of formulation development and manufacture for development programs. The individual will have a proven track record of effectively managing a global network of highly qualified Contract-Research Organizations (CROs) and Contract Development and Manufacturing Organizations (CDMOs).
Responsibilities:

* Design, direct and oversee small molecule formulation development, and manufacturing, with emphasis on the manufacture of registration and validation batches for later-stage assets.
* Develop strategic project and resource plans for company drug development programs, and provide high-level guidance to senior management on drug product requirements.
* Effectively lead and mentor team members in all matters related to drug product development that complies with global regulatory requirements.
* Guide research and design of experiments, manage priorities, risks to meet corporate goals.
* Author appropriate CMC sections to support global regulatory submissions.
* Develop relationships and actively manage external parties (CROs, CDMOs, Raw material suppliers, consultants, etc.)
* Budget, manage financials and forecast all drug product-related expenses.
* Provide presentations and reports progress on multi-disciplinary development teams, including senior management.

Required Skills, Education and Experience:

* Ph.D. in pharmaceutical sciences, chemical engineering, organic chemistry, or related discipline with at least 15 years of related industrial experience.
* Extensive formulation and process development expertise across a broad range of dosage forms.
* Prior experience managing third parties and external service providers (domestic and international), with emphasis of late-phase late phase/commercial contract manufacturing organizations (CROs).
* Manufacturing experience and a good understanding of cGMP requirements.
* Understanding of drug substance, solid form science, and analytical chemistry as related to drug product development.
* Excellent interpersonal skills, including negotiation skills that ensure corporate outcomes, are met.
* Strong oral/written communication and presentation skills.
* Skilled in the preparation and review regulatory filings (including INDs, IMPDs, NDAs, briefing packages or other regulatory dossiers).
* Excellent risk management, problem-solving and crisis management skills.
* Ability to work in cross-functional teams as related to drug development.
* Well versed with the latest technologies, trends and practices in formulation development, manufacturing, and the outsourcing industry.

Availability:

* Must be available to work in the evenings and weekends, as required.

Position Location and/or Territory and Travel:

* Position is in the United States (Irvine, CA or Cambridge, MA).
* Position may require minimal travel, as needed.

Spectrum Pharmaceuticals is an equal opportunity employer, we evaluate qualified applicants without regard to race, color, religion, sex, national origin, disability, veteran status, and other protected characteristics.

Director of Quality Control

Spectrum Pharmaceuticals, Inc.
Irvine, CA
The Director of Quality Control is responsible for designing, planning, implementing, directing and evaluating a quality Control function which support analytical development and regulatory approval of products. This role requires extensive interaction with Pharmaceutical Operations, Quality Assurance, Quality Operations, Program and CMC project management, Regulatory Affairs, and CMOs.
Responsibilities:

* Develop, implement, maintain and continually assess a quality control function and a quality management system for applicable regulated activities to meet internal company standards and external regulatory and customer requirements, including but not limited to, the following tasks:
* Plan and coordinate all the analytical R&D and quality control activities.
* Establish robust analytical development strategies, plans and timelines.
* Generate release and stability specifications for raw materials, drug substances and drug products.
* Manage method development and method validation activities for drug substance, drug substance intermediates and finished drug products.
* Review stability study design, monitoring, reporting and data trend-analysis.
* Perform clinical material evaluation and COA generation.
* Manage method transfer activities to contract manufacturing organizations/testing laboratories.
* Review/approve, methods, protocols, validation reports etc.
* Provide leadership for deviations and investigations at contract manufacturing organizations/testing laboratories.
* Formulating and administering policies and standard operating procedures (SOPs) relating to the quality control function and the quality management system.
* Establishing and maintaining a document control system for QC procedures, work instructions and forms
* Ownership of test record review and COA creation.
* Developing and implementing appropriate quality control training for the team.
* Provide training and guidance to analytical development best practices.
* Contribute to Annual Product Reviews.
* Prepare and review analytical sections of CMC for regulatory submissions and annual reports.
* Preparation and leadership for regulatory inspections.
* Implementing, performing and overseeing internal quality auditing of QC function (including applicable vendors or subcontractors), customer quality audit response, and other QC related quality management system activities.
* Define, develop and implement short-term and long-term strategies, goals, objectives and tactics relating to the quality control function and the quality management system.
* Review and recommend appropriate corrective action to ensure consistency with the quality control function and the quality management system.
* Implement a continuous improvement plan for growing and maturing the quality control function and the quality management system, including the following tasks:
* Performing periodic internal quality control system reviews and audits
* Designing, developing, implementing and enforcing best practices, processes, guidelines, systems, and technology to support and enhance the quality control function and the quality management system.
* Analyzing performance of quality control function and quality management system activities and documented resolutions, identifying problem areas, and devising and delivering solutions to enhance quality control and prevent future issues.
* Represent quality control function and related processes in connection with internal or external audits, inspections, monitoring visits and new business development activities, and assist with quality-related information related to (but not limited to) client assessments, RFPs, contracts and other documentation
* Maintain current knowledge base of regulations, corporate policies and standards to ensure that the quality control function and the quality management system remain in compliance with applicable regulatory and corporate standards/requirements and current with industry trends and best practices.
* Support strategic planning by timely communicating Quality deliverables, constraints, risks and options, and collaborating with Technical Development, Program management, Clinical, Commercial, Supply Chain, and internal and external Manufacturing teams.
* Identify risks and assumptions in plans, anticipate problems and plan for contingencies. Remove obstacles to move work forward and/or to get efforts back on track.

Skills, Education and Experience:

* Bachelor's Degree is required (Chemistry, Biological sciences, Engineering or related degree); advanced degree is a plus.
* Minimum of 10 years related experience in the Pharmaceutical/Biopharmaceutical/Biotechnology industry.
* Ideally a minimum of 8 years of experience in leading Analytical Development/Quality Control function, preferably at the Director level.
* Proven ability to effectively develop, communicate, and gain support for execution plans and strategies with a wide range of stakeholders.
* Leadership and management skills to grow and manage a high performing Quality organization.
* Demonstrated skills in project management and working with vendors and contractors
* Expert background in FDA, ISO, EMA, GMP and ICH requirements ideally for ATMPs.
* Proven experience with regulatory submissions, ideally for products which were ultimately approved for commercial distribution, and regulatory inspections.
* Excellent judgment and creative problem-solving skills, including negotiation and conflict resolution skills, excellent interpersonal skills, organizational skills, written and oral communication skills
* Ability to work in a fast paced and dynamic environment that will require management of several competing priorities while driving all projects forward and meeting program/project deliverables
* Energetic, flexible, collaborative and proactive; a leader who can positively and productively impact initiatives.

Availability:

* Must be available to work in the evenings and weekends, as required.

Position Location and/or Territory and Travel

* Position is located in the United States - Irvine, CA or Boston, MA.
* Position may require up to 30% travel (or) occasional local travel.

Spectrum Pharmaceuticals is an equal opportunity employer. We evaluate qualified applicants without regard to race, color. Religion, sex, national origin, disability, veteran status, and other protected characteristics.

Director of Program Management

Spectrum Pharmaceuticals, Inc.
Irvine, CA

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Spectrum Pharmaceuticals, Inc.
Irvine, CA

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Spectrum Pharmaceuticals, Inc.
Denver, CO

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