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Career Opportunities at Spectrum Pharmaceuticals
Spectrum Pharmaceuticals, Inc. (NASDAQ: SPPI), is a biopharmaceutical company that acquires, develops and commercializes a diversified portfolio of oncology and other drug candidates that meet critical health challenges for which there are few other treatment options. Spectrum’s expertise lies in identifying undervalued drugs with demonstrated safety and efficacy, and adding value through further clinical development and selection of the most viable and low-risk methods of commercialization. The Company’s pipeline includes promising early and late-stage drug candidates with unique formulations and mechanisms of action that address the needs of seriously ill patients, such as at-home chemotherapy and new treatment regimens for refractory disease.
Our passion to identify, develop and deliver better options for people suffering from cancer is behind every action we take. At Spectrum, each one of us is committed to excellence and strives to make a difference every day.
Search Firm Representatives:
Spectrum is not currently accepting unsolicited resumes from search firms. Regardless of past practice, all resumes submitted by search firms to any employee at Spectrum via-email or the Internet in any form without a valid written search agreement in place for that specific position will be deemed the sole property of Spectrum. As a result, no fee will be paid in the event the candidate is hired by Spectrum.
Please select from the list of available positions below to view the respective job description.
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This position will be responsible for establishing, implementing, and maintaining Spectrum Pharmaceuticals Quality Systems SOPs related to Quality Control for Chemistry and Microbiology.
The candidate will be responsible for analytical data review and certify lots for clinical and commercial release, annual product review, stability studies, manage analytical investigations (equipment, stability, out of specification (OOS), establish specifications for early development and clinical products per ICH guidelines, assist with laboratory audits, method development, and method transfer.
Primary Responsibilities
to include:
- Review and approve analytical data package for API & finished drug products from contract test laboratories (CTL) for clinical and commercial use.
- Issue C of A to release API and drug product (intermediate, bulk or finished drug product) for both clinical and commercial products.
- Write, review and approve SOPs, test methods, specifications, protocols, reports, shipment of samples (clinical, stability, commercial etc) and other documentation related to QC and analytical testing.
- Perform a comprehensive review and assessment of stability data (including trending of analytical data and OOS investigations). The candidate will perform statistical analysis of stability data for comparability studies and shelf-life projections.
- Audit all CTL and support the QA group for quality systems audits of contract manufacturing sites.
- Prepare stability sections for regulatory/QC documents in support of IND, NDA, PASs and CBEs, including annual product reviews, annual stability reports and annual reports.
- Provide analytical expertise/support to Product Development group in the selection of vendors for early development products.
- Manage directly or through associates the qualification/validation of analytical methods at CTL. Responsibilities include technical review and approval of validation protocols and reports, specifications, batch records and changes related to methods and specification.
- Establish and control Quality Assurance programs, laboratory procedures at CTL to ensure conformance and compliance to Spectrum Pharmaceuticals Quality Policies, procedures and regulatory standards.
- Additional job responsibilities include; maintenance of certified reference standards, implementation and maintenance of stability protocols and studies for a variety of late phase clinical as well as commercial products and training members of the analytical development/product development groups.
Job Qualifications:
- Minimum B. Sc/M. Sc. degree in chemistry, biochemistry, or microbiology with 5 -10 years experience in the Pharmaceutical or biotechnology industry.
- Demonstrated knowledge of GXPs, ICH, and other regulatory guidelines for testing, and release of pharmaceutical products.
- Extensive experience handling commercial and clinical release, OOS investigations and auditing vendors with close attention to detail and adherence to cGMPs.
- Experience working with contract facilities is preferred.
- Experienced in analytical techniques such as HPLC, GC, UV, wet chemistry, IR and in development and validation of analytical methods.
- Experience in sterility and endotoxin testing, Environmental Monitoring, Media Fills.
- Ability to effectively deal and negotiate with representatives from government agencies and clients.
- Ability to work independently and in a team environment.
- Strong working knowledge of Word, Excel, PowerPoint, LIMS database and statistical software are required.
- Excellent written, oral, communication and organizational skills, leadership, training and interpersonal skills are necessary.
- Must be able to travel domestically and internationally (5-15%).
Salary and Benefits:
Salary Commensurate with experience.
Benefits Program including health,
dental, vision, life, AD&D
and long-term disability, 401K
with Company matching.
Position Type: Full Time,
Employee
Contact:
Respond immediately with résumé and
cover letter indicating Job Title
to:
jobs@spectrumpharm.com |
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Under general supervision, the Clinical Research Associate (CRA)
will assist with coordination of clinical studies within the Clinical
Research Operations area. A CRA is expected to demonstrate initiative
and originality in organizing, systematizing and coordinating
clinical research activities.
Primary Responsibilities to include:
- Demonstrate superior communication and
organizational skills
in addition to the technical skills required for overseeing
clinical studies.
- Recognize the urgency
of meeting established
schedules and be able to prioritize tasks and time to meet those schedules.
- Help identify and select
trial sites. Conduct
qualification, initiation, interim monitoring close-out visits, and perform drug
accountability (approximately
50% travel required).
- Ensure the timely collection
of appropriate
regulatory documents from study sites.
- Assist in the development
of materials
that support the conduct of clinical studies including: site reference manuals,
monitoring flow sheets, CRF completion
guidelines, etc.)
- Review clinical documents
for accuracy
and completion (1572, consents, protocols, meeting minutes, etc).
- Assist in the preparation
of investigator ’s meetings.
- Remain current with applicable
regulations
concerning development and conduct of human clinical trials (CFRs, ICH). Communicate
to investigators the rudiments
of GCP
and their related responsibilities.
- Demonstrate
working knowledge of relevant
clinical trial SOPs.
- Ensure assigned studies
adhere
to approved protocols.
- Maintain a level of accuracy
that
minimizes data query rate and ensures data are accurately transcribed to meet
SOP and audit expectations. Identify and
provide
solutions for data trends.
Job Qualifications:
- Have a fundamental understanding of clinical research.
- Have a working knowledge
of the relevant SOPs.
- Have the necessary interpersonal
and communication skills
to establish professional working relationships with colleagues and site personnel.
- MS Word, Excel, in-depth
knowledge of other
presentation programs a plus.
- Minimum BA or BS degree
with 1+ years in
a clinical research environment.
- Strong, organizational
planning and
follow-through skills.
- Excellent language and
grammar skills,
ability to write clearly and concisely.
- Attention
to detail and the ability
to prioritize.
- Ability to work well under
pressure
and with tight schedules.
- Ability to plan and schedule
workload
and work effectively with others.
- Ability to exercise judgment
within
generally defined practices and policies for obtaining data.
- Self-direction and motivation
are
mandatory.
- Ability to resolve problems
positively and professionally.
Availability:
- Must have the quality-service
attitude and be willing
to work additional hours
to meet deadlines
- Required to make site visits (approximately 50% overnight
travel required).
Salary and Benefits:
Salary Commensurate with experience. Benefits Program including
health, dental, vision, life, AD&D and long-term disability,
401K with Company matching.
Position Type: Full Time, Employee
Contact:
Respond immediately with résumé and cover letter
indicating Job Title to:
jobs@spectrumpharm.com |
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Develop SAS programs for data cleaning and reporting. Create
customized listings/reports with SAS. Provide statistical programming
support under the direction of the senior staff for the creation
and maintenance of analysis data sets, tables, listings, and figures.
Primary Responsibilities to include:
- Create derived analysis datasets.
- Execute analyses specified
in the Statistical Analysis
Plan (SAP) under the
guidance of the project
statistician.
- Act as primary
programmer to produce tables,
listings, and figures
(TLFs) for
the clinical study report (CSR) and ad-hoc reports.
- Act as secondary programmer
to validate SAS programs
that produce derived
analysis
datasets and data analyses and ad-hoc reports.
- Assist Clinical Data Management
(CDM) group to design
or review database
structures,
and provide CRF listings for edit check purposes.
- Develop and Refine SOPs for
data handling, programming
and system validation.
Job Qualifications:
- Degree in Life Sciences, Computer Science, Statistics,
or related field
- General
knowledge of medical terminology
and clinical trial methodologies
- Bachelor’s degree with a
minimum 6yrs SAS programming
experience or a Master’s or
equivalent degree with
4 yrs SAS programming experience
- Strong SAS programming skills
with proficiency
in SAS/Base, SAS Stat, and SAS Macros with basic understanding of SAS/Graph
- Prior
experience working in the
pharmaceutical/Biotechnology
industry
- Ability to work independently
- Clear verbal and written
communication skills;
able to work with other cross function areas and CROs
- Excellent collaborative
skills and the ability
to manage complexity and change in a dynamic environment
Salary and Benefits:
Salary Commensurate with experience. Benefits Program including health, dental, vision, life, AD&D and long-term disability, 401K with Company matching.
Position Type: Full Time, Employee
Contact:
Respond immediately with résumé and cover letter
indicating Job Title to:
jobs@spectrumpharm.com |
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